Trial Outcomes & Findings for Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients (NCT NCT01271933)

NCT ID: NCT01271933

Last Updated: 2021-01-22

Results Overview

The time to loss of therapeutic response (LTR) is the time to loss of pain response (\<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

441 participants

Primary outcome timeframe

Randomization to Week 19

Results posted on

2021-01-22

Participant Flow

The study was performed in 4 countries at 50 centers.

Baseline phase was from Visit 1 to Visit 2. Eligible participants entered single blind (SB) phase (Visit 2 to Visit 6) \[6 weeks\]. Responders with at least 50% improvement in pain from baseline at the end of SB phase were considered for double blind (DB) phase (Visit 6 to Visit 9) \[13 weeks\]. All subjects entered 1 week taper phase after completion.

Participant milestones

Participant milestones
Measure	Pregabalin (Single Blind Phase) Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \[Week 1\], Visit 4 \[Week 2\], and Visit 5 \[Week 3\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.	Pregabalin (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase STARTED	441	0	0
Single-Blind Phase COMPLETED	320	0	0
Single-Blind Phase NOT COMPLETED	121	0	0
Double-Blind Phase STARTED	0	63	59
Double-Blind Phase Treated	0	63	58
Double-Blind Phase COMPLETED	0	46	47
Double-Blind Phase NOT COMPLETED	0	17	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin (Single Blind Phase) Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \[Week 1\], Visit 4 \[Week 2\], and Visit 5 \[Week 3\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.	Pregabalin (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase Lack of Efficacy	37	0	0
Single-Blind Phase Lost to Follow-up	10	0	0
Single-Blind Phase Withdrawal by Subject	15	0	0
Single-Blind Phase Protocol Violation	3	0	0
Single-Blind Phase Adverse Event	52	0	0
Single-Blind Phase (Failed to meet dosing requirement)	1	0	0
Single-Blind Phase (Protocol non-compliance)	2	0	0
Single-Blind Phase (Participant request-personal reason)	1	0	0
Double-Blind Phase Randomized but not treated	0	0	1
Double-Blind Phase Lack of Efficacy	0	6	9
Double-Blind Phase Lost to Follow-up	0	1	1
Double-Blind Phase Withdrawal by Subject	0	6	1
Double-Blind Phase Adverse Event	0	3	0
Double-Blind Phase Participant request-personal reason	0	1	0

Baseline Characteristics

Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin (Single Blind Phase) n=441 Participants Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \[Week 1\], Visit 4 \[Week 2\], and Visit 5 \[Week 3\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.
Age, Customized <18 years	0 Participants n=5 Participants
Age, Customized 18 - 44 years	178 Participants n=5 Participants
Age, Customized 45 - 64 years	227 Participants n=5 Participants
Age, Customized ≥ 65 years	36 Participants n=5 Participants
Sex: Female, Male Female	392 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Randomization to Week 19

Population: Full analysis set (FAS) included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Time to Loss of Therapeutic Response (LTR)	58 Days Interval 45.0 to Not available was due to an insufficient number of events in a given arm to calculate the upper limit.	23 Days Interval 14.0 to 41.0	—

PRIMARY outcome

Timeframe: Randomization to Week 19

Population: FAS included all participants randomized to the double blind phase who received at least one dose of study medication in the double blind phase.

Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Number of Participants With Loss of Therapeutic Response (LTR) Event	34 Participants	41 Participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Population: Single-blind analysis set (SBAS) consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 Week 1	-0.9 Units on a scale Standard Deviation 1.17	—	—
Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 Week 2	-1.5 Units on a scale Standard Deviation 1.51	—	—
Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 Week 3	-2.0 Units on a scale Standard Deviation 1.85	—	—
Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 Week 4	-2.3 Units on a scale Standard Deviation 2.01	—	—
Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 Week 5	-2.5 Units on a scale Standard Deviation 2.00	—	—
Single-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 1, 2, 3, 4, 5, 6 Week 6	-2.6 Units on a scale Standard Deviation 2.13	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Population: Full analysis set (FAS) consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 7	-3.9 Units on a scale Standard Deviation 1.49	-3.0 Units on a scale Standard Deviation 1.59	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 8	-3.7 Units on a scale Standard Deviation 1.72	-2.7 Units on a scale Standard Deviation 1.99	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 9	-3.6 Units on a scale Standard Deviation 2.01	-2.8 Units on a scale Standard Deviation 1.91	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 10	-3.7 Units on a scale Standard Deviation 1.96	-2.4 Units on a scale Standard Deviation 2.01	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 11	-3.7 Units on a scale Standard Deviation 2.21	-2.6 Units on a scale Standard Deviation 1.94	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 12	-3.7 Units on a scale Standard Deviation 1.98	-2.6 Units on a scale Standard Deviation 1.82	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 13	-3.6 Units on a scale Standard Deviation 2.10	-2.6 Units on a scale Standard Deviation 2.21	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 14	-3.5 Units on a scale Standard Deviation 2.11	-2.5 Units on a scale Standard Deviation 2.14	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 15	-3.6 Units on a scale Standard Deviation 2.30	-2.6 Units on a scale Standard Deviation 2.24	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 16	-3.4 Units on a scale Standard Deviation 2.22	-2.6 Units on a scale Standard Deviation 1.94	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 17	-3.6 Units on a scale Standard Deviation 2.02	-2.5 Units on a scale Standard Deviation 1.82	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 18	-3.4 Units on a scale Standard Deviation 2.53	-2.5 Units on a scale Standard Deviation 1.93	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 19	-3.4 Units on a scale Standard Deviation 2.59	-2.4 Units on a scale Standard Deviation 2.11	—
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 20	-3.0 Units on a scale Standard Deviation 2.82	-4.9 Units on a scale Standard Deviation 2.74	—

SECONDARY outcome

Timeframe: Baseline, Double blind endpoint visit (Week 19)

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.

Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=62 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Mean Daily Pain Score at Double Blind Endpoint Visit	-2.9 Units on a scale Interval -3.5 to -2.3	-2.5 Units on a scale Interval -3.1 to -1.9	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 Week 1	-0.7 Units on a scale Standard Deviation 1.16	—	—
Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 Week 2	-1.2 Units on a scale Standard Deviation 1.53	—	—
Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 Week 3	-1.6 Units on a scale Standard Deviation 1.91	—	—
Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 Week 4	-2.0 Units on a scale Standard Deviation 2.08	—	—
Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 Week 5	-2.2 Units on a scale Standard Deviation 2.10	—	—
Single-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 1, 2, 3, 4, 5, 6 Week 6	-2.3 Units on a scale Standard Deviation 2.17	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired).

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 7	-3.4 Units on a scale Standard Deviation 1.74	-3.0 Units on a scale Standard Deviation 1.79	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 8	-3.3 Units on a scale Standard Deviation 1.81	-2.8 Units on a scale Standard Deviation 1.95	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 9	-3.2 Units on a scale Standard Deviation 1.93	-2.9 Units on a scale Standard Deviation 1.98	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 10	-3.2 Units on a scale Standard Deviation 2.03	-2.6 Units on a scale Standard Deviation 1.93	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 11	-3.1 Units on a scale Standard Deviation 2.16	-2.5 Units on a scale Standard Deviation 1.91	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 12	-3.4 Units on a scale Standard Deviation 1.77	-2.5 Units on a scale Standard Deviation 1.69	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 13	-3.2 Units on a scale Standard Deviation 1.82	-2.6 Units on a scale Standard Deviation 1.87	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 14	-3.2 Units on a scale Standard Deviation 2.06	-2.5 Units on a scale Standard Deviation 1.95	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 15	-3.4 Units on a scale Standard Deviation 2.15	-2.6 Units on a scale Standard Deviation 1.96	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 16	-3.1 Units on a scale Standard Deviation 2.15	-2.7 Units on a scale Standard Deviation 1.84	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 17	-3.4 Units on a scale Standard Deviation 1.88	-2.5 Units on a scale Standard Deviation 1.96	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 18	-3.2 Units on a scale Standard Deviation 2.24	-2.4 Units on a scale Standard Deviation 1.82	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 19	-3.1 Units on a scale Standard Deviation 2.23	-2.4 Units on a scale Standard Deviation 1.96	—
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Week 20	-2.7 Units on a scale Standard Deviation 2.42	-4.9 Units on a scale Standard Deviation 1.48	—

SECONDARY outcome

Timeframe: Baseline, Double blind endpoint visit (Week 19)

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=62 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Average Daily Tiredness Score at Double Blind Endpoint Visit	-2.6 Units on a scale Interval -3.2 to -2.0	-2.5 Units on a scale Interval -3.1 to -1.9	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Wake after Sleep Onset (Week 1)	-19.1 Minutes Standard Deviation 45.90	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Wake after Sleep Onset (Week 2)	-22.4 Minutes Standard Deviation 50.22	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Wake after Sleep Onset (Week 3)	-25.0 Minutes Standard Deviation 64.57	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Wake after Sleep Onset (Week 4)	-27.5 Minutes Standard Deviation 62.58	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Wake after Sleep Onset (Week 5)	-31.4 Minutes Standard Deviation 57.37	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Wake after Sleep Onset (Week 6)	-32.8 Minutes Standard Deviation 59.51	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Latency to Sleep Onset (Week 1)	-10.3 Minutes Standard Deviation 42.35	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Latency to Sleep Onset (Week 2)	-13.0 Minutes Standard Deviation 43.25	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Latency to Sleep Onset (Week 3)	-15.5 Minutes Standard Deviation 49.01	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Latency to Sleep Onset (Week 4)	-19.6 Minutes Standard Deviation 49.84	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Latency to Sleep Onset (Week 5)	-20.0 Minutes Standard Deviation 52.32	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep and Subjective Latency to Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective Latency to Sleep Onset (Week 6)	-16.9 Minutes Standard Deviation 47.34	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication. Here, 'overall number of participants analyzed' signifies participants who awakened after sleep.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=439 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective No.of Awakenings after Sleep (Week 1)	-0.8 Number of times the participant awakened Standard Deviation 1.28	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective No.of Awakenings after Sleep (Week 2)	-1.0 Number of times the participant awakened Standard Deviation 1.50	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective No.of Awakenings after Sleep (Week 3)	-1.1 Number of times the participant awakened Standard Deviation 1.54	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective No.of Awakenings after Sleep (Week 4)	-1.1 Number of times the participant awakened Standard Deviation 1.44	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective No.of Awakenings after Sleep (Week 5)	-1.2 Number of times the participant awakened Standard Deviation 1.70	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Number of Awakenings After Sleep Onset at Weeks 1, 2, 3, 4, 5, 6 Subjective No.of Awakenings after Sleep (Week 6)	-1.2 Number of times the participant awakened Standard Deviation 1.52	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 Subjective Total Sleep Time (Week 1)	0.6 Hours Standard Deviation 0.93	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 Subjective Total Sleep Time (Week 2)	0.6 Hours Standard Deviation 0.96	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 Subjective Total Sleep Time (Week 3)	0.6 Hours Standard Deviation 1.00	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 Subjective Total Sleep Time (Week 4)	0.7 Hours Standard Deviation 0.94	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 Subjective Total Sleep Time (Week 5)	0.7 Hours Standard Deviation 1.00	—	—
Single-Blind Phase: Change From Baseline in Daily SSQ - Subjective Total Sleep Time at Weeks 1, 2, 3, 4, 5, 6 Subjective Total Sleep Time (Week 6)	0.7 Hours Standard Deviation 1.08	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=439 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 Sleep quality (Week 1)	1.0 Units on a scale Standard Deviation 1.35	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 Sleep quality (Week 2)	1.2 Units on a scale Standard Deviation 1.43	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 Sleep quality (Week 3)	1.5 Units on a scale Standard Deviation 1.75	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 Sleep quality (Week 4)	1.6 Units on a scale Standard Deviation 1.79	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 Sleep quality (Week 5)	1.7 Units on a scale Standard Deviation 1.82	—	—
Single-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 1, 2, 3, 4, 5, 6 Sleep quality (Week 6)	1.7 Units on a scale Standard Deviation 1.89	—	—

SECONDARY outcome

Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 9)	-18.4 Minutes Standard Deviation 34.03	-16.0 Minutes Standard Deviation 50.97	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 14)	-20.8 Minutes Standard Deviation 25.58	-21.8 Minutes Standard Deviation 44.03	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 19)	-16.7 Minutes Standard Deviation 29.38	-19.5 Minutes Standard Deviation 50.89	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 7)	-27.8 Minutes Standard Deviation 37.29	-32.0 Minutes Standard Deviation 50.47	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 8)	-27.4 Minutes Standard Deviation 39.39	-28.0 Minutes Standard Deviation 56.99	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 9)	-27.0 Minutes Standard Deviation 40.12	-33.2 Minutes Standard Deviation 56.45	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 10)	-26.9 Minutes Standard Deviation 38.92	-26.2 Minutes Standard Deviation 68.24	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 11)	-29.0 Minutes Standard Deviation 44.80	-37.4 Minutes Standard Deviation 56.79	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 12)	-26.0 Minutes Standard Deviation 46.00	-31.0 Minutes Standard Deviation 43.96	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 13)	-22.8 Minutes Standard Deviation 37.78	-31.4 Minutes Standard Deviation 50.08	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 14)	-27.0 Minutes Standard Deviation 39.87	-43.3 Minutes Standard Deviation 54.45	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 15)	-31.7 Minutes Standard Deviation 38.37	-35.1 Minutes Standard Deviation 56.47	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 16)	-25.9 Minutes Standard Deviation 41.95	-35.0 Minutes Standard Deviation 52.67	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 17)	-31.5 Minutes Standard Deviation 34.29	-36.2 Minutes Standard Deviation 58.67	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 18)	-32.4 Minutes Standard Deviation 36.37	-37.3 Minutes Standard Deviation 56.67	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 19)	-27.3 Minutes Standard Deviation 52.27	-23.1 Minutes Standard Deviation 46.28	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Wake after Sleep Onset (Week 20)	-22.5 Minutes Standard Deviation 11.03	-7.1 Minutes Standard Deviation 11.15	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 7)	-15.6 Minutes Standard Deviation 55.67	-19.1 Minutes Standard Deviation 41.02	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 8)	-19.1 Minutes Standard Deviation 29.70	-12.3 Minutes Standard Deviation 42.83	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 10)	-19.5 Minutes Standard Deviation 29.40	-18.0 Minutes Standard Deviation 43.83	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Latency to Sleep Onset (Week 11)	-18.5 Minutes Standard Deviation 22.40	-18.0 Minutes Standard Deviation 47.82	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 12)	-16.3 Minutes Standard Deviation 26.04	-18.8 Minutes Standard Deviation 40.31	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 13)	-17.5 Minutes Standard Deviation 20.79	-16.8 Minutes Standard Deviation 36.51	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 15)	-19.4 Minutes Standard Deviation 20.25	-19.1 Minutes Standard Deviation 42.55	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 16)	-15.8 Minutes Standard Deviation 31.85	-20.9 Minutes Standard Deviation 42.18	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 17)	-23.1 Minutes Standard Deviation 23.09	-20.9 Minutes Standard Deviation 49.30	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 18)	-16.3 Minutes Standard Deviation 24.52	-18.7 Minutes Standard Deviation 46.23	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Latency to Sleep Onset (Week 20)	23.0 Minutes Standard Deviation 84.31	-28.7 Minutes Standard Deviation 8.00	—

SECONDARY outcome

Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 10)	-1.2 Number of times the participant awakened Standard Deviation 1.10	-0.9 Number of times the participant awakened Standard Deviation 1.16	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 15)	-0.8 Number of times the participant awakened Standard Deviation 2.20	-1.1 Number of times the participant awakened Standard Deviation 1.21	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 7)	-1.1 Number of times the participant awakened Standard Deviation 1.39	-1.0 Number of times the participant awakened Standard Deviation 1.30	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 8)	-1.2 Number of times the participant awakened Standard Deviation 1.23	-0.8 Number of times the participant awakened Standard Deviation 1.27	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 9)	-1.2 Number of times the participant awakened Standard Deviation 0.94	-1.1 Number of times the participant awakened Standard Deviation 1.12	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 11)	-1.1 Number of times the participant awakened Standard Deviation 1.40	-0.9 Number of times the participant awakened Standard Deviation 1.18	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 12)	-1.1 Number of times the participant awakened Standard Deviation 1.50	-0.8 Number of times the participant awakened Standard Deviation 1.00	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 13)	-1.0 Number of times the participant awakened Standard Deviation 1.02	-1.0 Number of times the participant awakened Standard Deviation 1.13	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 14)	-1.0 Number of times the participant awakened Standard Deviation 1.06	-1.1 Number of times the participant awakened Standard Deviation 1.07	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 16)	-1.0 Number of times the participant awakened Standard Deviation 1.10	-1.0 Number of times the participant awakened Standard Deviation 1.18	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 17)	-1.2 Number of times the participant awakened Standard Deviation 0.92	-0.9 Number of times the participant awakened Standard Deviation 1.25	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 18)	-1.1 Number of times the participant awakened Standard Deviation 1.14	-1.0 Number of times the participant awakened Standard Deviation 1.28	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 19)	-0.7 Number of times the participant awakened Standard Deviation 2.63	-0.9 Number of times the participant awakened Standard Deviation 1.32	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective No.of Awakenings after Sleep (Week 20)	-1.5 Number of times the participant awakened Standard Deviation 1.14	-1.5 Number of times the participant awakened Standard Deviation 0.95	—

SECONDARY outcome

Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 7)	0.7 Hours Standard Deviation 1.00	0.5 Hours Standard Deviation 1.10	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 8)	0.9 Hours Standard Deviation 0.89	0.6 Hours Standard Deviation 1.25	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 9)	0.8 Hours Standard Deviation 1.00	0.5 Hours Standard Deviation 1.10	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 10)	0.9 Hours Standard Deviation 1.07	0.5 Hours Standard Deviation 1.01	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 11)	0.9 Hours Standard Deviation 0.86	0.6 Hours Standard Deviation 1.08	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 12)	0.8 Hours Standard Deviation 1.01	0.5 Hours Standard Deviation 1.13	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 13)	0.7 Hours Standard Deviation 0.93	0.6 Hours Standard Deviation 0.95	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 14)	0.9 Hours Standard Deviation 1.31	0.7 Hours Standard Deviation 1.17	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 15)	0.7 Hours Standard Deviation 0.90	0.7 Hours Standard Deviation 1.22	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 16)	0.7 Hours Standard Deviation 0.94	0.7 Hours Standard Deviation 1.04	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 17)	0.7 Hours Standard Deviation 0.85	0.7 Hours Standard Deviation 1.08	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 18)	0.6 Hours Standard Deviation 0.85	0.5 Hours Standard Deviation 1.23	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 19)	0.5 Hours Standard Deviation 1.10	0.6 Hours Standard Deviation 1.15	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Subjective Total Sleep Time (Week 20)	-0.1 Hours Standard Deviation 1.02	0.5 Hours Standard Deviation 0.41	—

SECONDARY outcome

Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 10)	2.2 Units on a scale Standard Deviation 1.70	1.7 Units on a scale Standard Deviation 1.74	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 13)	1.9 Units on a scale Standard Deviation 1.72	1.9 Units on a scale Standard Deviation 1.63	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 17)	2.2 Units on a scale Standard Deviation 1.71	1.9 Units on a scale Standard Deviation 1.72	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 7)	1.9 Units on a scale Standard Deviation 1.69	1.9 Units on a scale Standard Deviation 1.62	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 8)	2.0 Units on a scale Standard Deviation 1.61	1.7 Units on a scale Standard Deviation 1.71	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 9)	2.1 Units on a scale Standard Deviation 1.47	1.8 Units on a scale Standard Deviation 1.66	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 11)	2.3 Units on a scale Standard Deviation 1.78	1.7 Units on a scale Standard Deviation 1.63	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 12)	2.1 Units on a scale Standard Deviation 1.66	1.7 Units on a scale Standard Deviation 1.65	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 14) N=48,43	2.2 Units on a scale Standard Deviation 1.69	2.1 Units on a scale Standard Deviation 1.73	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 15)	2.2 Units on a scale Standard Deviation 1.76	2.0 Units on a scale Standard Deviation 1.64	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 16)	1.9 Units on a scale Standard Deviation 1.87	1.9 Units on a scale Standard Deviation 1.68	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 18)	2.1 Units on a scale Standard Deviation 1.64	1.8 Units on a scale Standard Deviation 1.71	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 19)	2.0 Units on a scale Standard Deviation 1.77	1.5 Units on a scale Standard Deviation 1.55	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 Sleep Quality (Week 20)	3.1 Units on a scale Standard Deviation 1.23	3.3 Units on a scale Standard Deviation 0.45	—

SECONDARY outcome

Timeframe: Baseline, Double blind endpoint visit (Week 19)

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=62 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit Subjective Wake after Sleep Onset	-26.2 Minutes Interval -36.6 to -15.8	-20.6 Minutes Interval -30.7 to -10.5	—
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset and Subjective Latency to Sleep Onset at Double Blind Endpoint Visit Subjective Latency to Sleep Onset	-10.6 Minutes Interval -24.2 to 3.0	-11.9 Minutes Interval -25.0 to 1.3	—

SECONDARY outcome

Timeframe: Baseline, Double blind endpoint visit (Week 19)

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=62 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset at Double Blind Endpoint Visit	-0.5 Number of times the participant awakened Interval -1.1 to 0.1	-0.8 Number of times the participant awakened Interval -1.4 to -0.2	—

SECONDARY outcome

Timeframe: Baseline, Double blind endpoint visit (Week 19)

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=62 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time at Double Blind Endpoint Visit	0.6 Hours Interval 0.3 to 0.9	0.4 Hours Interval 0.1 to 0.7	—

SECONDARY outcome

Timeframe: Baseline, Double blind endpoint visit (Week 19)

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=62 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Daily Subjective Sleep Questionnaire (SSQ) - Sleep Quality at Double Blind Endpoint Visit	1.9 Units on a scale Interval 1.4 to 2.4	1.4 Units on a scale Interval 1.0 to 1.9	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain).

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=289 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Weekly Pain Score at Week 6 (1 Week Recall Period)	-1.6 Units on a scale Standard Deviation 2.18	—	—

SECONDARY outcome

Timeframe: Baseline, Week 19

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=60 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=57 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Weekly Pain Score at Week 19 (1 Week Recall Period)	-3.1 Units on a scale Interval -3.8 to -2.4	-2.4 Units on a scale Interval -3.1 to -1.7	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Sleep disturbance	-21.8 Units on a scale Standard Deviation 24.82	—	—
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Snoring	-1.0 Units on a scale Standard Deviation 24.94	—	—
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Awakening Short of Breath/with a Headache	-11.0 Units on a scale Standard Deviation 30.59	—	—
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Sleep adequacy	18.9 Units on a scale Standard Deviation 31.17	—	—
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Somnolence	-3.6 Units on a scale Standard Deviation 24.87	—	—
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Sleep Problems Index I	-16.1 Units on a scale Standard Deviation 21.62	—	—
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6 - Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Sleep Problems Index II	-15.9 Units on a scale Standard Deviation 20.44	—	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 6- Quantity of Sleep	0.7 hours Standard Deviation 1.33	—	—

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Somnolence	-11.9 Units on a scale Interval -17.8 to -5.9	-6.6 Units on a scale Interval -12.4 to -0.9	—
Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Sleep Problems Index II	-19.7 Units on a scale Interval -25.4 to -14.0	-14.0 Units on a scale Interval -19.5 to -8.6	—
Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Sleep disturbance	-25.4 Units on a scale Interval -32.0 to -18.8	-15.5 Units on a scale Interval -21.8 to -9.1	—
Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Snoring	-2.4 Units on a scale Interval -5.2 to 9.9	-2.9 Units on a scale Interval -10.1 to 4.3	—
Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Awakening Short of Breath/with a Headache	-8.1 Units on a scale Interval -13.5 to -2.7	-4.2 Units on a scale Interval -9.3 to -0.9	—
Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Sleep adequacy	23.9 Units on a scale Interval 16.0 to 31.9	17.1 Units on a scale Interval 9.5 to 24.8	—
Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19-Sleep Disturbance, Snoring, Awakening Short of Breath or With a Headache, Sleep Adequacy, Somnolence, Sleep Problems Index I and Sleep Problems Index II Sleep Problems Index I	-19.5 Units on a scale Interval -25.0 to -13.9	-13.7 Units on a scale Interval -19.0 to -8.3	—

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 19- Quantity of Sleep	0.7 hours Interval 0.4 to 1.0	0.5 hours Interval 0.2 to 0.8	—

SECONDARY outcome

Timeframe: Week 6

PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=289 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 Very Much Improved	24 Participants	—	—
Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 Much Improved	77 Participants	—	—
Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 Minimally Improved	103 Participants	—	—
Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 No Change	46 Participants	—	—
Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 Minimally Worse	16 Participants	—	—
Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 Much Worse	18 Participants	—	—
Single-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 6 Very Much Worse	5 Participants	—	—

SECONDARY outcome

Timeframe: Week 19

PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=60 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=57 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 Very Much Improved	7 Participants	7 Participants	—
Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 Much Improved	15 Participants	11 Participants	—
Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 Minimally Improved	14 Participants	12 Participants	—
Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 No Change	9 Participants	11 Participants	—
Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 Minimally Worse	7 Participants	6 Participants	—
Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 Much Worse	7 Participants	8 Participants	—
Double-Blind Phase: Number of Participants Who Reported Global Impression of Change (PGIC) at Week 19 Very Much Worse	1 Participants	2 Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 SF-36 Physical Functioning	14.0 Units on a scale Standard Deviation 19.89	—	—
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 SF-36 Role-Physical	17.8 Units on a scale Standard Deviation 27.38	—	—
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 SF-36 Pain Index	20.7 Units on a scale Standard Deviation 22.07	—	—
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 SF-36 General Health Perceptions	8.5 Units on a scale Standard Deviation 17.96	—	—
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 SF-36 Vitality	18.2 Units on a scale Standard Deviation 24.35	—	—
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 SF-36 Social Functioning	12.9 Units on a scale Standard Deviation 28.19	—	—
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 SF-36 Role-Emotional	8.6 Units on a scale Standard Deviation 29.40	—	—
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 SF-36 Mental Health Index	7.9 Units on a scale Standard Deviation 18.94	—	—
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 Physical Component Score	7.2 Units on a scale Standard Deviation 8.75	—	—
Single-Blind Phase: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 6 Mental Component Score	4.5 Units on a scale Standard Deviation 11.78	—	—

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 SF-36 Role-Emotional	3.8 Units on a scale Interval -4.1 to 11.7	2.2 Units on a scale Interval -5.4 to 9.8	—
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 SF-36 Physical Functioning	12.4 Units on a scale Interval 6.4 to 18.4	13.7 Units on a scale Interval 8.0 to 19.5	—
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 SF-36 Role-Physical	18.9 Units on a scale Interval 11.7 to 26.0	16.2 Units on a scale Interval 9.4 to 23.1	—
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 SF-36 Pain Index	19.2 Units on a scale Interval 12.5 to 26.0	16.0 Units on a scale Interval 9.5 to 22.5	—
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 SF-36 General Health Perceptions	3.3 Units on a scale Interval -1.8 to 8.3	9.3 Units on a scale Interval 4.5 to 14.2	—
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 SF-36 Vitality	12.2 Units on a scale Interval 5.3 to 19.1	15.7 Units on a scale Interval 9.1 to 22.3	—
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 SF-36 Social Functioning	13.3 Units on a scale Interval 7.0 to 19.6	13.5 Units on a scale Interval 7.4 to 19.5	—
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 SF-36 Mental Health Index	6.6 Units on a scale Interval 1.4 to 11.7	5.2 Units on a scale Interval 0.3 to 10.2	—
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 Physical Component Score	6.8 Units on a scale Interval 4.2 to 9.4	7.2 Units on a scale Interval 4.7 to 9.7	—
Double-Blind Phase: Change From Baseline in SF-36 Score at Week 19 Mental Component Score	2.6 Units on a scale Interval -0.6 to 5.8	2.4 Units on a scale Interval -0.7 to 5.5	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6 HADS-A Anxiety scale	-1.8 Units on a scale Standard Deviation 3.47	—	—
Single-Blind Phase: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 6 HADS-D Depression scale	-1.5 Units on a scale Standard Deviation 3.62	—	—

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in HADS Score at Week 19 HADS-A Anxiety scale	-0.7 Units on a scale Interval -1.7 to 0.4	-1.6 Units on a scale Interval -2.6 to -0.6	—
Double-Blind Phase: Change From Baseline in HADS Score at Week 19 HADS-D Depression scale	-1.4 Units on a scale Interval -2.3 to -0.4	-1.1 Units on a scale Interval -2.0 to -0.2	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 8: Stiffness	-1.8 Units on a scale Standard Deviation 2.65	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 1: Physical activities	-0.9 Units on a scale Standard Deviation 2.14	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 2: Feel good	-2.2 Units on a scale Standard Deviation 3.33	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 3: Work missed	-0.5 Units on a scale Standard Deviation 2.42	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 4: Do job	-1.5 Units on a scale Standard Deviation 2.72	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 5: Pain	-1.6 Units on a scale Standard Deviation 2.25	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 6: Fatigue	-1.4 Units on a scale Standard Deviation 2.43	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 7: Rested	-1.7 Units on a scale Standard Deviation 2.65	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 9: Anxiety	-1.2 Units on a scale Standard Deviation 2.95	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Item 10: Depression	-0.6 Units on a scale Standard Deviation 2.75	—	—
Single-Blind Phase: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Week 6 Total Score	-13.4 Units on a scale Standard Deviation 16.71	—	—

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 1: Physical activities	-1.0 Units on a scale Interval -1.6 to -0.4	-1.3 Units on a scale Interval -1.9 to -0.8	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 2: feel good	-3.0 Units on a scale Interval -3.9 to -2.1	-3.2 Units on a scale Interval -4.1 to -2.3	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 3: Work missed	-1.2 Units on a scale Interval -1.7 to -0.7	-1.0 Units on a scale Interval -1.5 to -0.5	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 4: Do job	-2.1 Units on a scale Interval -3.0 to -1.3	-2.2 Units on a scale Interval -3.0 to -1.4	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 5: Pain	-2.7 Units on a scale Interval -3.4 to -2.0	-2.2 Units on a scale Interval -2.8 to -1.5	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 6: Fatigue	-2.3 Units on a scale Interval -3.0 to -1.6	-2.4 Units on a scale Interval -3.0 to -1.7	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 7: Rested	-2.6 Units on a scale Interval -3.4 to -1.8	-2.2 Units on a scale Interval -3.0 to -1.4	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 8: Stiffness	-2.4 Units on a scale Interval -3.2 to -1.6	-2.2 Units on a scale Interval -3.0 to -1.4	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 9: Anxiety	-1.8 Units on a scale Interval -2.6 to -1.0	-1.7 Units on a scale Interval -2.5 to -0.9	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Item 10: Depression	-0.7 Units on a scale Interval -1.4 to 0.0	-0.7 Units on a scale Interval -1.3 to 0.0	—
Double-Blind Phase: Change From Baseline in FIQ Score at Week 19 Total Score	-19.6 Units on a scale Interval -25.3 to -13.9	-19.1 Units on a scale Interval -24.6 to -13.7	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6 General fatigue	-0.2 Units on a scale Standard Deviation 2.47	—	—
Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6 Physical fatigue	0.1 Units on a scale Standard Deviation 2.67	—	—
Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6 Reduced activity	-0.2 Units on a scale Standard Deviation 2.55	—	—
Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6 Reduced motivation	0.2 Units on a scale Standard Deviation 2.71	—	—
Single-Blind Phase: Change From Baseline in Multidimensional Fatigue Inventory (MFI) at Week 6 Mental fatigue	-0.1 Units on a scale Standard Deviation 2.17	—	—

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in MFI Score at Week 19 General fatigue	0.1 Units on a scale Interval -0.4 to 0.6	-0.1 Units on a scale Interval -0.6 to 0.3	—
Double-Blind Phase: Change From Baseline in MFI Score at Week 19 Physical fatigue	-0.1 Units on a scale Interval -0.6 to 0.5	0.2 Units on a scale Interval -0.3 to 0.7	—
Double-Blind Phase: Change From Baseline in MFI Score at Week 19 Reduced activity	0.0 Units on a scale Interval -0.5 to 0.6	-0.3 Units on a scale Interval -0.7 to 0.2	—
Double-Blind Phase: Change From Baseline in MFI Score at Week 19 Reduced motivation	1.0 Units on a scale Interval 0.4 to 1.5	0.3 Units on a scale Interval -0.2 to 0.8	—
Double-Blind Phase: Change From Baseline in MFI Score at Week 19 Mental fatigue	-0.1 Units on a scale Interval -0.5 to 0.3	0.1 Units on a scale Interval -0.3 to 0.4	—

SECONDARY outcome

Timeframe: Week 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Benefit from treatment-No	69 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Benefit from treatment-Little benefit	137 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Benefit from treatment-much benefit	211 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Satisfaction from treatment-very dissatisfied	52 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Satisfaction from treatment-a little dissatisfied	59 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Satisfaction from treatment-a little satisfied	103 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Satisfaction from treatment-very satisfied	203 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Willing to continue treatment-very unwilling	68 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Willing to continue treatment-little unwilling	33 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Willing to continue treatment-little bit willing	49 Participants	—	—
Single-Blind Phase: Number of Participants With Benefit, Satisfaction, Willingness to Continue Measure (BSW) at Week 6 Willing to continue treatment-very willing	266 Participants	—	—

SECONDARY outcome

Timeframe: Week 19

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed"= participants evaluable for specified categories.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=57 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Benefit from treatment-No	3 Participants	11 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Benefit from treatment-Little benefit	15 Participants	16 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Benefit from treatment-much benefit	41 Participants	30 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Satisfaction from treatment-very dissatisfied	4 Participants	6 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Satisfaction from treatment-a little dissatisfied	10 Participants	8 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Satisfaction from treatment-a little satisfied	10 Participants	13 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Satisfaction from treatment-very satisfied	36 Participants	30 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Willing to continue treatment-very unwilling	8 Participants	4 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Willing to continue treatment-little unwilling	6 Participants	8 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Willing to continue treatment-little bit willing	9 Participants	11 Participants	—
Double-Blind Phase: Number of Participants With Benefit, Satisfaction, and Willingness (BSW) to Continue Data at Visit 9 (3 Component Questions) at Week 19 Willing to continue treatment-very willing	37 Participants	34 Participants	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6 Percent Work Time Missed	-5.8 Units on a scale Standard Deviation 48.69	—	—
Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6 Percent Impairment While Working	-10.0 Units on a scale Standard Deviation 31.29	—	—
Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6 Percent Activity Impairment	-13.5 Units on a scale Standard Deviation 25.88	—	—
Single-Blind Phase: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 6 Percent Overall Work Impairment	-12.3 Units on a scale Standard Deviation 27.62	—	—

SECONDARY outcome

Timeframe: Baseline, Week 19

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19 Percent Work Time Missed	-7.3 Units on a scale Interval -21.3 to 6.7	-26.7 Units on a scale Interval -41.0 to -12.3	—
Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19 Percent Impairment While Working	-14.0 Units on a scale Interval -19.7 to -8.2	-15.0 Units on a scale Interval -20.8 to -9.3	—
Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19 Percent Activity Impairment	-16.4 Units on a scale Interval -19.0 to -13.7	-19.6 Units on a scale Interval -22.1 to -17.0	—
Double-Blind Phase: Change From Baseline WPAI Questionnaire at Week 19 Percent Overall Work Impairment	-15.9 Units on a scale Interval -18.7 to -13.1	-17.5 Units on a scale Interval -20.2 to -14.8	—

SECONDARY outcome

Timeframe: Baseline, Double blind end point visit (Week 19)

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=44 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=38 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Double Blind End Point Visit (Week 19)	-182.7 Counts of total daytime activity Interval -20143.1 to 19777.7	-6672.2 Counts of total daytime activity Interval -26663.5 to 13319.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7 Total Sleep Time (Week 3)	-0.1 Hours Standard Deviation 0.94	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7 Total Sleep Time (Week 4)	0.4 Hours Standard Deviation 0.99	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7 Total Sleep Time (Week 5)	0.3 Hours Standard Deviation 1.02	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7 Total Sleep Time (Week 6)	0.3 Hours Standard Deviation 1.15	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 3, 4, 5, 6 and 7 Total Sleep Time (Week 7)	0.6 Hours Standard Deviation 1.10	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7 Minutes of Interrupted Sleep (Week 3)	-5.3 Minutes Standard Deviation 12.63	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7 Minutes of Interrupted Sleep (Week 4)	-5.9 Minutes Standard Deviation 16.10	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7 Minutes of Interrupted Sleep (Week 5)	-7.0 Minutes Standard Deviation 15.66	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7 Minutes of Interrupted Sleep (Week 6)	-6.6 Minutes Standard Deviation 16.12	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 3, 4, 5, 6 and 7 Minutes of Interrupted Sleep (Week 7)	0.7 Minutes Standard Deviation 19.43	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7 Sleep Fragmentation Index (Week 3)	-0.8 Percentage of immobile bouts Standard Deviation 5.27	—	—
Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7 Sleep Fragmentation Index (Week 4)	-2.5 Percentage of immobile bouts Standard Deviation 5.45	—	—
Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7 Sleep Fragmentation Index (Week 5)	-2.8 Percentage of immobile bouts Standard Deviation 5.27	—	—
Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7 Sleep Fragmentation Index (Week 6)	-2.6 Percentage of immobile bouts Standard Deviation 5.63	—	—
Single-Blind Phase: Change From Baseline at in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index Weeks 3, 4, 5, 6 and 7 Sleep Fragmentation Index (Week 7)	0.7 Percentage of immobile bouts Standard Deviation 5.85	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7 Total daytime activity (Week 3)	10264.3 Counts of total daytime activity Standard Deviation 90090.07	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7 Total daytime activity (Week 4)	10588.1 Counts of total daytime activity Standard Deviation 59150.38	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7 Total daytime activity (Week 5)	8635.8 Counts of total daytime activity Standard Deviation 54823.64	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7 Total daytime activity (Week 6)	7134.2 Counts of total daytime activity Standard Deviation 58221.22	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 3, 4, 5, 6 and 7 Total daytime activity (Week 7)	18420.7 Counts of total daytime activity Standard Deviation 61725.84	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7

Population: SBAS consisted of all participants who were enrolled into the SB phase of the study and received at least 1 dose of study medication.

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7 Percent Sedentary (Week 3)	0.7 Percent of daytime Standard Deviation 6.66	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7 Percent Sedentary (Week 4)	0.7 Percent of daytime Standard Deviation 5.61	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7 Percent Sedentary (Week 5)	0.6 Percent of daytime Standard Deviation 5.62	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7 Percent Sedentary (Week 6)	0.3 Percent of daytime Standard Deviation 6.07	—	—
Single-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 3, 4, 5, 6 and 7 Percent Sedentary (Week 7)	0.2 Percent of daytime Standard Deviation 5.51	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15 Total Sleep Time (Week 11)	0.5 Hours Standard Deviation 0.91	0.0 Hours Standard Deviation 1.53	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15 Total Sleep Time (Week 12)	0.5 Hours Standard Deviation 1.23	0.1 Hours Standard Deviation 1.01	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15 Total Sleep Time (Week 13)	0.4 Hours Standard Deviation 1.15	0.1 Hours Standard Deviation 1.15	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15 Total Sleep Time (Week 14)	0.4 Hours Standard Deviation 1.02	0.1 Hours Standard Deviation 1.14	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Sleep Time at Weeks 11, 12, 13, 14 and 15 Total Sleep Time (Week 15)	0.2 Hours Standard Deviation 0.91	0.3 Hours Standard Deviation 1.13	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15 Minutes of Interrupted Sleep (Week 11)	-9.0 Minutes Standard Deviation 10.27	2.5 Minutes Standard Deviation 18.97	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15 Minutes of Interrupted Sleep (Week 12)	-3.0 Minutes Standard Deviation 14.77	-1.7 Minutes Standard Deviation 14.10	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15 Minutes of Interrupted Sleep (Week 13)	-3.0 Minutes Standard Deviation 20.33	0.4 Minutes Standard Deviation 14.14	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15 Minutes of Interrupted Sleep (Week 14)	-3.2 Minutes Standard Deviation 19.12	-1.8 Minutes Standard Deviation 13.19	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Weeks 11, 12, 13, 14 and 15 Minutes of Interrupted Sleep (Week 15)	-0.4 Minutes Standard Deviation 25.03	-0.5 Minutes Standard Deviation 13.73	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15 Sleep Fragmentation Index (Week 11)	-4.4 Percentage of immobile bouts Standard Deviation 5.53	0.1 Percentage of immobile bouts Standard Deviation 5.17	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15 Sleep Fragmentation Index (Week 12)	-2.8 Percentage of immobile bouts Standard Deviation 5.91	-0.4 Percentage of immobile bouts Standard Deviation 6.29	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15 Sleep Fragmentation Index (Week 13)	-2.2 Percentage of immobile bouts Standard Deviation 7.28	-0.3 Percentage of immobile bouts Standard Deviation 5.23	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15 Sleep Fragmentation Index (Week 14)	-2.4 Percentage of immobile bouts Standard Deviation 7.32	-0.6 Percentage of immobile bouts Standard Deviation 4.75	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Weeks 11, 12, 13, 14 and 15 Sleep Fragmentation Index (Week 15)	-0.9 Percentage of immobile bouts Standard Deviation 7.41	-0.9 Percentage of immobile bouts Standard Deviation 5.19	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15 Total daytime activity ((Week 14)	-179.7 Counts of total daytime activity Standard Deviation 55858.35	-4523.8 Counts of total daytime activity Standard Deviation 52629.95	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15 Total daytime activity (Week 11)	-1894.1 Counts of total daytime activity Standard Deviation 46879.81	-2083.9 Counts of total daytime activity Standard Deviation 40939.67	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15 Total daytime activity ((Week 12)	-50.7 Counts of total daytime activity Standard Deviation 50114.87	-6691.1 Counts of total daytime activity Standard Deviation 47353.03	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15 Total daytime activity ((Week 13)	-4362.4 Counts of total daytime activity Standard Deviation 51922.75	521.8 Counts of total daytime activity Standard Deviation 46996.71	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Total Daytime Activity at Weeks 11, 12, 13, 14 and 15 Total daytime activity ((Week 15)	-4138.3 Counts of total daytime activity Standard Deviation 54924.02	-4649.4 Counts of total daytime activity Standard Deviation 58121.16	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15

Population: FAS consisted of all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase.

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15 Percent Sedentary (Week 11)	-0.7 Percent of daytime Standard Deviation 7.72	1.1 Percent of daytime Standard Deviation 6.69	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15 Percent Sedentary (Week 12)	-0.8 Percent of daytime Standard Deviation 5.66	-1.4 Percent of daytime Standard Deviation 6.15	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15 Percent Sedentary (Week 13)	-1.3 Percent of daytime Standard Deviation 5.41	-0.9 Percent of daytime Standard Deviation 6.15	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15 Percent Sedentary (Week 14)	-2.1 Percent of daytime Standard Deviation 6.56	-1.1 Percent of daytime Standard Deviation 7.27	—
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Weeks 11, 12, 13, 14 and 15 Percent Sedentary (Week 15)	-1.5 Percent of daytime Standard Deviation 5.21	-1.4 Percent of daytime Standard Deviation 6.56	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Double blind end point visit (Week 19)

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=44 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=38 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment- Total Sleep Time at Double Blind End Point Visit (Week 19)	0.5 Hours Interval 0.1 to 0.9	0.1 Hours Interval -0.3 to 0.5	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Double blind end point visit (Week 19)

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=44 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=38 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Minutes of Interrupted Sleep at Double Blind End Point Visit (Week 19)	-3.5 Minutes Interval -10.0 to 2.9	-2.3 Minutes Interval -8.8 to 4.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Double blind end point visit (Week 19)

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=44 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=38 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Sleep Fragmentation Index at Double Blind End Point Visit (Week 19)	-2.5 Percentage of immobile bouts Interval -4.6 to -0.5	-0.6 Percentage of immobile bouts Interval -2.6 to 1.4	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Double blind end point visit (Week 19)

Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=44 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=38 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Double-Blind Phase: Change From Baseline in Actigraphy Functional/Sleep Assessment - Percent Sedentary at Double Blind End Point Visit (Week 19)	-1.4 Percent of daytime Interval -3.6 to 0.8	-2.0 Percent of daytime Interval -4.2 to 0.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 1 to Week 7 and Week 11 to Week 20

Population: The population in the single and double blind phase consisted of all paticipants who received at least 1 dose of study medication and who received at least 1 dose of study medication.

C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 \[not at all\] to 4 \[extremely\]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm.

Outcome measures

Outcome measures
Measure	Pregabalin (Double Blind Phase) n=441 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=63 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 Participants At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) Week 1	5 Participants	—	—
Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) Week 2	6 Participants	—	—
Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) Week 3	4 Participants	—	—
Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) Week 6	16 Participants	—	—
Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) Week 7	10 Participants	—	—
Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) Week 11	—	3 Participants	0 Participants
Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) Week 15	—	1 Participants	1 Participants
Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) Week 19	—	1 Participants	3 Participants
Number of Participants With Suicidal Ideation Throughout the Study Assessed by Columbia Classification Algorithm of Suicide Assessment (C-CASA) Week 20	—	1 Participants	1 Participants

Adverse Events

Pregabalin (Single Blind Phase)

Serious events: 5 serious events

Other events: 353 other events

Deaths: 0 deaths

Pregabalin (Double Blind Phase)

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo (Double Blind Phase)

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pregabalin (Single Blind Phase) n=441 participants at risk Participants were treated with pregabalin 165 mg/day during the initial week of the SB phase.Subsequently, the pregabalin dose could have been increased based on efficacy and tolerability at each weekly visit (Visit 3 \[Week 1\], Visit 4 \[Week 2\], and Visit 5 \[Week 3\]).The dose could have been decreased at or between the weekly visits,up to and including Visit 5 (Week 3). The dose could only be changed by 1 step (up or down) at a time (eg, 165 mg/day to 330 mg/day, or 495 mg/day to 330 mg/day).After the end of the third week of the SB phase (Visit 5), no further dose optimization was permitted. Participants unable to tolerate a dose of at least 330 mg/day by Visit 5 (Week 3) were discontinued from the study.During the next 3 weeks of the SB phase, the optimized dose was provided. Participants unable to tolerate the optimized dose of study medication were discontinued from the study.	Pregabalin (Double Blind Phase) n=63 participants at risk At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase, or placebo. Participants randomized to pregabalin, received pregabalin at the optimized dose (330 to 495 mg/day) during the first week and thereafter. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.	Placebo (Double Blind Phase) n=58 participants at risk At Visit 6 (Week 6), participants were randomized to receive either pregabalin at the optimized dose determined during the SB phase,or placebo.For participants randomized to placebo, the first week of the DB phase included a blinded taper to placebo. After DB baseline, all observed and volunteered AEs regardless of treatment or casually related to investigational product(s) were reported.
Ear and labyrinth disorders Vertigo	0.00% 0/441 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.6% 1/63 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Glossitis	0.23% 1/441 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/63 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.23% 1/441 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/63 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Cellulitis	0.23% 1/441 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/63 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.23% 1/441 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/63 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Investigations Hypertension	0.23% 1/441 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/63 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/441 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	1.6% 1/63 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Post-traumatic stress disorder	0.23% 1/441 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/63 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/58 • From time that the participant provided informed consent through and including 28 calender days after the last administration of the investigational product (up to Week 20) The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER