Trial Outcomes & Findings for Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (NCT NCT01049217)

Last Updated: 2021-01-28

Results Overview

Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

377 participants

Primary outcome timeframe

Baseline, Endpoint (up to Week 16)

Results posted on

2021-01-28

Participant Flow

All participants received placebo matched to pregabalin capsule orally twice daily for 2 weeks in placebo lead-in phase prior to randomization.

Participant milestones

Participant milestones
Measure	Pregabalin Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Study STARTED	183	194
Overall Study Treated	183	192
Overall Study COMPLETED	127	131
Overall Study NOT COMPLETED	56	63

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Overall Study Adverse Event	2	1
Overall Study Lack of Efficacy	1	1
Overall Study Lost to Follow-up	3	8
Overall Study Withdrawal by Subject	4	3
Overall Study Protocol Violation	1	3
Overall Study Pregnancy	1	0
Overall Study Study Terminated by Sponsor	43	43
Overall Study Other	1	2
Overall Study Randomized but not Treated	0	2

Baseline Characteristics

Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Total n=375 Participants Total of all reporting groups
Age, Continuous	41.2 years STANDARD_DEVIATION 9.0 • n=5 Participants	42.3 years STANDARD_DEVIATION 8.4 • n=7 Participants	41.7 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	121 Participants n=5 Participants	116 Participants n=7 Participants	237 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	76 Participants n=7 Participants	138 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Endpoint (up to Week 16)

Population: Intent to Treat (ITT) population: all randomized participants who took at least 1 dose of study drug. Imputation: mBOCF, baseline data was carried forward for participants who discontinued due to adverse events or had no post-baseline observations; otherwise last observation carried forward (LOCF).

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Change From Baseline in Mean Pain Score at Endpoint (up to Week 16) Baseline	6.76 units on a scale Standard Deviation 1.194	6.85 units on a scale Standard Deviation 1.222
Change From Baseline in Mean Pain Score at Endpoint (up to Week 16) Change at Endpoint	-2.26 units on a scale Standard Deviation 2.200	-2.36 units on a scale Standard Deviation 2.288

SECONDARY outcome

Timeframe: Week 16

Population: ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.

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). Number of participants in each category is reported.

Outcome measures

Outcome measures
Measure	Pregabalin n=173 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=176 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) Very Much Improved	42 participants	51 participants
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) Much Improved	69 participants	66 participants
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) Minimally Improved	42 participants	36 participants
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) No Change	13 participants	17 participants
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) Minimally Worse	5 participants	2 participants
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) Much Worse	2 participants	4 participants
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGIC) Very Much Worse	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 16

Population: ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure.

The CGIC scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported.

Outcome measures

Outcome measures
Measure	Pregabalin n=172 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=176 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) Very Much Improved	45 participants	47 participants
Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) Much Improved	59 participants	53 participants
Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) Minimally Improved	48 participants	49 participants
Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) No Change	17 participants	25 participants
Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) Minimally Worse	3 participants	2 participants
Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) Much Worse	0 participants	0 participants
Number of Participants With Categorical Scores on Clinician Global Impression of Change (CGIC) Very Much Worse	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)

Population: ITT population: all randomized participants who took at least 1 dose of study drug. N (number of participants analyzed) signifies those participants who were evaluable for this measure. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.

Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=191 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 7 (n=145, 145)	-2.06 units on a scale Standard Deviation 2.234	-1.94 units on a scale Standard Deviation 1.987
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Baseline (n=183, 191)	6.55 units on a scale Standard Deviation 1.643	6.70 units on a scale Standard Deviation 1.456
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 1 (n=177, 182)	-0.48 units on a scale Standard Deviation 1.067	-0.37 units on a scale Standard Deviation 1.003
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 2 (n=168, 170)	-0.85 units on a scale Standard Deviation 1.317	-0.66 units on a scale Standard Deviation 1.292
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 3 (n=163, 163)	-1.09 units on a scale Standard Deviation 1.505	-0.81 units on a scale Standard Deviation 1.373
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 4 (n=153, 160)	-1.42 units on a scale Standard Deviation 1.804	-1.20 units on a scale Standard Deviation 1.665
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 5 (n=150, 159)	-1.81 units on a scale Standard Deviation 1.952	-1.49 units on a scale Standard Deviation 1.824
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 6 (n=144, 152)	-1.95 units on a scale Standard Deviation 2.125	-1.81 units on a scale Standard Deviation 1.903
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 8 (n=139, 145)	-2.01 units on a scale Standard Deviation 2.194	-2.04 units on a scale Standard Deviation 2.103
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 9 (n=135, 137)	-2.45 units on a scale Standard Deviation 2.382	-2.32 units on a scale Standard Deviation 2.154
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 10 (n=131, 135)	-2.48 units on a scale Standard Deviation 2.315	-2.39 units on a scale Standard Deviation 2.175
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 11 (n=125, 133)	-2.56 units on a scale Standard Deviation 2.393	-2.47 units on a scale Standard Deviation 2.207
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 12 (n=122, 131)	-2.69 units on a scale Standard Deviation 2.354	-2.59 units on a scale Standard Deviation 2.291
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 13 (n=118, 127)	-2.73 units on a scale Standard Deviation 2.337	-2.82 units on a scale Standard Deviation 2.262
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 14 (n=118, 129)	-2.81 units on a scale Standard Deviation 2.442	-2.90 units on a scale Standard Deviation 2.346
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 15 (n=117, 127)	-2.90 units on a scale Standard Deviation 2.438	-2.95 units on a scale Standard Deviation 2.325
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 16 (n=103, 121)	-3.14 units on a scale Standard Deviation 2.475	-2.94 units on a scale Standard Deviation 2.324
Change From Baseline in Numeric Rating Scale (NRS)-Sleep Interference Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Endpoint (n=183, 189)	-2.40 units on a scale Standard Deviation 2.323	-2.43 units on a scale Standard Deviation 2.296

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)

Population: ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively. Missing data for endpoint (up to Week 16) imputed using LOCF.

Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current ("right now") HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 4 (n=158, 169)	-1.41 units on a scale Standard Deviation 1.682	-1.17 units on a scale Standard Deviation 1.649
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Baseline (n=183, 192)	6.66 units on a scale Standard Deviation 1.208	6.71 units on a scale Standard Deviation 1.245
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 1 (n=181, 190)	-0.43 units on a scale Standard Deviation 1.000	-0.34 units on a scale Standard Deviation 0.917
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 2 (n=174, 179)	-0.79 units on a scale Standard Deviation 1.236	-0.67 units on a scale Standard Deviation 1.282
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 3 (n=170, 172)	-1.10 units on a scale Standard Deviation 1.440	-0.82 units on a scale Standard Deviation 1.410
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 5 (n=157, 166)	-1.74 units on a scale Standard Deviation 1.893	-1.48 units on a scale Standard Deviation 1.845
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 6 (n=152, 157)	-1.87 units on a scale Standard Deviation 2.042	-1.73 units on a scale Standard Deviation 1.965
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 7 (n=153, 153)	-1.92 units on a scale Standard Deviation 2.074	-1.88 units on a scale Standard Deviation 2.006
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 8 (n=148, 153)	-2.01 units on a scale Standard Deviation 2.106	-1.99 units on a scale Standard Deviation 2.105
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 9 (n=143, 148)	-2.30 units on a scale Standard Deviation 2.199	-2.21 units on a scale Standard Deviation 2.180
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 10 (n=138, 142)	-2.38 units on a scale Standard Deviation 2.172	-2.24 units on a scale Standard Deviation 2.225
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 11 (n=132, 136)	-2.42 units on a scale Standard Deviation 2.250	-2.37 units on a scale Standard Deviation 2.218
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 12 (n=128, 135)	-2.55 units on a scale Standard Deviation 2.241	-2.44 units on a scale Standard Deviation 2.247
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 13 (n=126, 133)	-2.53 units on a scale Standard Deviation 2.241	-2.60 units on a scale Standard Deviation 2.208
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 14 (n=124, 131)	-2.66 units on a scale Standard Deviation 2.307	-2.74 units on a scale Standard Deviation 2.303
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 15 (n=120, 132)	-2.77 units on a scale Standard Deviation 2.283	-2.78 units on a scale Standard Deviation 2.283
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Week 16 (n=111, 128)	-2.94 units on a scale Standard Deviation 2.370	-2.81 units on a scale Standard Deviation 2.353
Change From Baseline in Numeric Rating Scale (NRS)-Current Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and Endpoint (up to Week 16) Change at Endpoint (n=183, 191)	-2.24 units on a scale Standard Deviation 2.239	-2.29 units on a scale Standard Deviation 2.302

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)

BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=182 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Baseline: PSI (n=182, 192)	6.49 units on a scale Standard Deviation 1.175	6.47 units on a scale Standard Deviation 1.292
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Week 4: PSI (n=158, 169)	-1.55 units on a scale Standard Deviation 1.725	-1.28 units on a scale Standard Deviation 1.811
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Week 8: PSI (n=146, 154)	-2.15 units on a scale Standard Deviation 2.142	-2.02 units on a scale Standard Deviation 2.117
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Week 12: PSI (n=126, 137)	-2.49 units on a scale Standard Deviation 2.311	-2.60 units on a scale Standard Deviation 2.169
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Week 16: PSI (n=166, 166)	-2.38 units on a scale Standard Deviation 2.335	-2.55 units on a scale Standard Deviation 2.354
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Endpoint: PSI (n=175,182)	-2.36 units on a scale Standard Deviation 2.291	-2.44 units on a scale Standard Deviation 2.334
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Baseline: PII (n=182, 192)	5.51 units on a scale Standard Deviation 1.963	5.44 units on a scale Standard Deviation 2.013
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Week 4: PII (n=158, 169)	-1.43 units on a scale Standard Deviation 2.068	-1.40 units on a scale Standard Deviation 2.358
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Week 8: PII (n=146, 154)	-2.00 units on a scale Standard Deviation 2.319	-1.97 units on a scale Standard Deviation 2.312
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Week 12: PII (n=126, 137)	-2.32 units on a scale Standard Deviation 2.450	-2.32 units on a scale Standard Deviation 2.183
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Week 16: PII (n=166, 165)	-2.14 units on a scale Standard Deviation 2.434	-2.38 units on a scale Standard Deviation 2.290
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score at Week 4, 8, 12, 16 and Endpoint (up to Week 16) Change at Endpoint: PII (n=175,182)	-2.12 units on a scale Standard Deviation 2.415	-2.31 units on a scale Standard Deviation 2.306

SECONDARY outcome

Timeframe: Baseline, Endpoint (up to Week 16)

NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Pressure of Area (n=173, 176)	-2.5 units on a scale Standard Deviation 2.75	-2.3 units on a scale Standard Deviation 2.99
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Burning (n=173, 176)	-2.4 units on a scale Standard Deviation 2.91	-2.6 units on a scale Standard Deviation 3.06
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Pressure of Area (n=183, 192)	6.0 units on a scale Standard Deviation 2.12	6.0 units on a scale Standard Deviation 2.25
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Burning (n=183, 192)	6.1 units on a scale Standard Deviation 2.33	6.2 units on a scale Standard Deviation 2.52
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Squeezing (n=183, 192)	5.3 units on a scale Standard Deviation 2.57	5.2 units on a scale Standard Deviation 2.98
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Squeezing (n=173, 176)	-2.1 units on a scale Standard Deviation 3.02	-2.1 units on a scale Standard Deviation 3.03
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Pressure (n=183, 192)	5.8 units on a scale Standard Deviation 2.50	5.5 units on a scale Standard Deviation 2.73
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Pressure (n=172, 176)	-2.3 units on a scale Standard Deviation 3.19	-2.2 units on a scale Standard Deviation 3.15
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Electric Shocks (n=183, 192)	5.4 units on a scale Standard Deviation 2.76	5.1 units on a scale Standard Deviation 2.84
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Electric Shocks (n=173, 176)	-2.2 units on a scale Standard Deviation 3.18	-2.0 units on a scale Standard Deviation 3.10
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Stabbing (n=183, 192)	5.8 units on a scale Standard Deviation 2.46	6.1 units on a scale Standard Deviation 2.58
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Stabbing (n=173, 176)	-2.2 units on a scale Standard Deviation 3.00	-2.5 units on a scale Standard Deviation 3.11
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Light Touching (n=183, 192)	5.0 units on a scale Standard Deviation 2.60	5.0 units on a scale Standard Deviation 2.62
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Light Touching (n=173, 176)	-1.9 units on a scale Standard Deviation 2.91	-1.9 units on a scale Standard Deviation 3.05
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Cold of Area (n=183, 192)	5.9 units on a scale Standard Deviation 2.56	5.5 units on a scale Standard Deviation 2.87
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Cold of Area (n=173, 176)	-2.2 units on a scale Standard Deviation 2.98	-2.0 units on a scale Standard Deviation 3.07
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Pins and Needles (n=183, 192)	6.7 units on a scale Standard Deviation 2.14	6.6 units on a scale Standard Deviation 2.23
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Pins and Needles (n=173, 176)	-2.6 units on a scale Standard Deviation 2.90	-2.6 units on a scale Standard Deviation 3.12
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Baseline: Tingling (n=183, 192)	5.8 units on a scale Standard Deviation 2.49	6.1 units on a scale Standard Deviation 2.42
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Item Scores at Endpoint (up to Week 16) Change at Endpoint: Tingling (n=173, 176)	-2.1 units on a scale Standard Deviation 3.01	-2.4 units on a scale Standard Deviation 3.09

SECONDARY outcome

Timeframe: Baseline, Endpoint (up to Week 16)

NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours \[hrs\], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=173 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=176 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16) Duration of Spontaneous Pain, Worsened (n=173,172)	31 participants	33 participants
Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16) Duration of Spontaneous Pain, Improved (n=173,172)	86 participants	89 participants
Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16) Duration of Spontaneous Pain, Unchanged(n=173,172)	56 participants	50 participants
Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16) Number of Pain Attacks, Worsened (n=173, 176)	40 participants	25 participants
Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16) Number of Pain Attacks, Unchanged (n=173, 176)	49 participants	54 participants
Neuropathic Pain Symptom Inventory (NPSI): Change From Baseline in Number of Participants With Duration of Spontaneous Pain and Number of Pain Attacks at Endpoint (up to Week 16) Number of Pain Attacks, Improved (n=173, 176)	84 participants	97 participants

SECONDARY outcome

Timeframe: Baseline, Endpoint (up to Week 16)

NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Baseline: Burning Pain (n=183, 192)	0.61 units on a scale Standard Deviation 0.233	0.62 units on a scale Standard Deviation 0.252
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Change at Endpoint: Burning Pain (n=173, 176)	-0.24 units on a scale Standard Deviation 0.291	-0.26 units on a scale Standard Deviation 0.306
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Baseline: Pressing Pain (n=182, 192)	0.55 units on a scale Standard Deviation 0.227	0.54 units on a scale Standard Deviation 0.248
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Change at Endpoint: Pressing Pain (n=173, 176)	-0.22 units on a scale Standard Deviation 0.280	-0.21 units on a scale Standard Deviation 0.279
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Baseline: Paroxysmal Pain (n=183, 192)	0.56 units on a scale Standard Deviation 0.227	0.56 units on a scale Standard Deviation 0.236
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Change at Endpoint: Paroxysmal Pain (n=173, 176)	-0.22 units on a scale Standard Deviation 0.272	-0.23 units on a scale Standard Deviation 0.279
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Baseline: Evoked Pain (n=183, 192)	0.57 units on a scale Standard Deviation 0.202	0.55 units on a scale Standard Deviation 0.206
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Change at Endpoint: Evoked Pain (n=173, 176)	-0.22 units on a scale Standard Deviation 0.243	-0.21 units on a scale Standard Deviation 0.253
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Baseline: P/D (n=183, 192)	0.62 units on a scale Standard Deviation 0.211	0.63 units on a scale Standard Deviation 0.199
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Change at Endpoint: P/D (n=173, 176)	-0.23 units on a scale Standard Deviation 0.282	-0.25 units on a scale Standard Deviation 0.277
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Baseline: Total Score (n=182, 192)	0.58 units on a scale Standard Deviation 0.173	0.57 units on a scale Standard Deviation 0.175
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Subscales and Total Intensity Score at Endpoint (up to Week 16) Change at Endpoint: Total Score (n=173,176)	-0.22 units on a scale Standard Deviation 0.231	-0.23 units on a scale Standard Deviation 0.236

SECONDARY outcome

Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)

Population: ITT population. N (number of participants analyzed) = participants evaluable for this measure. Missing data for endpoint (up to Week 16) imputed using LOCF. Data for Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16 were collected and reported in individual participant listings but not statistically summarized for analysis.

Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=155 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=152 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS) Endpoint: TST	396.84 minutes Standard Error 5.04	400.29 minutes Standard Error 5.29
Total Sleep Time (TST) and Minutes of Interrupted Sleep (MIS) Endpoint: MIS	41.48 minutes Standard Error 1.45	45.14 minutes Standard Error 1.50

SECONDARY outcome

Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)

SFI is a measure to quantify sleep restlessness. SFI 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. SFI determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on wrist like a watch. It was programmed to record movements while device was being worn. Endpoint was the last observation for a participant assessed using imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=155 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=151 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Sleep Fragmentation Index (SFI)	18.57 percentage of immobile bouts Standard Error 0.47	19.60 percentage of immobile bouts Standard Error 0.49

SECONDARY outcome

Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)

Sleep efficiency is the time spent asleep divided by total time between sleep onset and sleep end, multiplied by 100. Sleep efficiency was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=155 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=151 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Sleep Efficiency	85.80 Percent time between sleep onset and end Standard Error 0.39	84.84 Percent time between sleep onset and end Standard Error 0.41

SECONDARY outcome

Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)

Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the "day" (non sleep period). A total activity count was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=152 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=151 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Total Activity Counts	297350 activity counts per day Standard Error 5280.2	305787 activity counts per day Standard Error 5480.9

SECONDARY outcome

Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)

Percentage of time above sedentary level is number of epochs (60 seconds) with greater than (\>) 200 activity counts per minute divided by total number of epochs during the "day" (non sleep period) multiplied by 100. This was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=155 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=152 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Percentage Day Time Above Sedentary Level	52.43 percentage of day time Standard Error 0.51	52.28 percentage of day time Standard Error 0.53

SECONDARY outcome

Timeframe: Baseline, Endpoint (up to Week 16)

Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. Endpoint was the last observation for a participant assessed using imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Baseline: Adequacy (n= 183, 192)	57.81 units on a scale Standard Deviation 25.776	54.22 units on a scale Standard Deviation 24.801
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Baseline: Sleep Disturbance (n=183, 192)	35.27 units on a scale Standard Deviation 22.127	39.32 units on a scale Standard Deviation 22.800
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Change at Endpoint: Sleep Disturbance (n=173, 175)	-6.58 units on a scale Standard Deviation 22.856	-8.64 units on a scale Standard Deviation 25.317
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Baseline: Snoring (n=181, 192)	25.30 units on a scale Standard Deviation 31.456	26.04 units on a scale Standard Deviation 34.077
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Change at Endpoint: Snoring (n=171, 175)	0.94 units on a scale Standard Deviation 35.301	-3.77 units on a scale Standard Deviation 33.862
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Baseline: SOB (n= 183, 192)	22.08 units on a scale Standard Deviation 27.216	25.83 units on a scale Standard Deviation 28.567
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Change at Endpoint: SOB (n=173, 175)	-3.01 units on a scale Standard Deviation 28.938	-7.09 units on a scale Standard Deviation 30.552
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Baseline: Quantity (n= 183, 192)	7.50 units on a scale Standard Deviation 1.969	7.96 units on a scale Standard Deviation 3.976
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Change at Endpoint: Quantity (n=173, 175)	0.27 units on a scale Standard Deviation 1.814	0.36 units on a scale Standard Deviation 2.082
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Change at Endpoint: Adequacy (n=173, 175)	5.26 units on a scale Standard Deviation 30.319	4.63 units on a scale Standard Deviation 30.091
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Baseline: Somnolence (n= 183, 192)	26.05 units on a scale Standard Deviation 21.078	29.10 units on a scale Standard Deviation 20.773
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Change at Endpoint: Somnolence (n=173, 175)	-0.77 units on a scale Standard Deviation 22.946	-4.23 units on a scale Standard Deviation 24.136
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Baseline: Sleep Problems Index (n= 183, 192)	32.97 units on a scale Standard Deviation 16.726	36.91 units on a scale Standard Deviation 16.862
Change From Baseline in Medical Outcomes Study-Sleep Scale (MOS-SS) at Endpoint (up to Week 16) Change at Endpoint:Sleep Problems Index(n=173,175)	-4.25 units on a scale Standard Deviation 17.382	-6.70 units on a scale Standard Deviation 18.358

SECONDARY outcome

Timeframe: Baseline, Endpoint (up to Week 16)

MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Endpoint was the last observation for a participant assessed using imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep Endpoint (n=173, 176)	80 participants	80 participants
Medical Outcomes Study-Sleep Scale (MOS-SS): Number of Participants With Optimal Sleep Baseline (n=183, 192)	80 participants	77 participants

SECONDARY outcome

Timeframe: Baseline, Endpoint (up to Week 16)

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. Endpoint was the last observation for a participant assessed using imputation method.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16) Baseline: HADS-A (n=183, 192)	5.99 units on a scale Standard Deviation 4.065	6.32 units on a scale Standard Deviation 4.216
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16) Change at Endpoint: HADS-A (n=173, 176)	-1.03 units on a scale Standard Deviation 4.550	-1.50 units on a scale Standard Deviation 4.593
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16) Baseline: HADS-D (n=183, 192)	4.92 units on a scale Standard Deviation 3.478	5.42 units on a scale Standard Deviation 3.885
Change From Baseline in Hospital Anxiety and Depression Scales (HADS) at Endpoint (up to Week 16) Change at Endpoint: HADS-D (n=173, 176)	0.07 units on a scale Standard Deviation 4.238	-1.02 units on a scale Standard Deviation 4.038

SECONDARY outcome

Timeframe: Baseline, Endpoint (up to Week 16)

SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical \[R-P\], role-emotional \[R-E\]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning).

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: BP (n=172, 176)	13.13 units on a scale Standard Deviation 24.846	12.86 units on a scale Standard Deviation 28.888
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: Ph Fn (n=183, 192)	55.25 units on a scale Standard Deviation 24.913	56.30 units on a scale Standard Deviation 24.444
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: Ph Fn (n=173, 176)	8.29 units on a scale Standard Deviation 26.438	6.85 units on a scale Standard Deviation 27.839
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: R-P (n=183, 192)	55.43 units on a scale Standard Deviation 25.806	58.37 units on a scale Standard Deviation 25.078
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: R-P (n=173, 176)	9.03 units on a scale Standard Deviation 27.012	7.05 units on a scale Standard Deviation 29.122
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: BP (n=183, 192)	48.11 units on a scale Standard Deviation 20.149	48.47 units on a scale Standard Deviation 21.855
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: GH (n=183, 192)	58.83 units on a scale Standard Deviation 20.583	59.47 units on a scale Standard Deviation 19.808
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: GH (n=173, 176)	8.25 units on a scale Standard Deviation 20.985	7.37 units on a scale Standard Deviation 21.300
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: Ph C (n=183, 192)	39.66 units on a scale Standard Deviation 8.632	40.06 units on a scale Standard Deviation 8.110
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: Ph C (n=171, 176)	4.44 units on a scale Standard Deviation 8.530	4.17 units on a scale Standard Deviation 9.528
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: Vit (n=183, 192)	61.01 units on a scale Standard Deviation 16.338	59.80 units on a scale Standard Deviation 18.443
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: Vit (n=172, 176)	2.86 units on a scale Standard Deviation 19.196	4.87 units on a scale Standard Deviation 21.014
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: So Fn (n=183, 192)	68.37 units on a scale Standard Deviation 22.498	66.34 units on a scale Standard Deviation 22.825
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: So Fn (n=173, 176)	2.60 units on a scale Standard Deviation 26.866	6.18 units on a scale Standard Deviation 23.299
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: R-E (n=183, 192)	63.80 units on a scale Standard Deviation 26.333	67.93 units on a scale Standard Deviation 25.214
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: R-E (n=173, 176)	6.74 units on a scale Standard Deviation 29.536	1.85 units on a scale Standard Deviation 29.307
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: MnH (n=183, 192)	69.07 units on a scale Standard Deviation 16.902	68.59 units on a scale Standard Deviation 19.133
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: MnH (n=172, 176)	3.11 units on a scale Standard Deviation 20.698	4.12 units on a scale Standard Deviation 19.776
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Baseline: Mn C (n=183, 192)	47.12 units on a scale Standard Deviation 10.037	47.18 units on a scale Standard Deviation 10.473
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Endpoint (up to Week 16) Change at Endpoint: Mn C (n=171, 176)	1.18 units on a scale Standard Deviation 11.394	1.21 units on a scale Standard Deviation 10.519

SECONDARY outcome

Timeframe: Baseline, Week 16, 17

Population: ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.

WPAI: 6-question participant rated questionnaire to determine the degree to which specific health problem (SHP) affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Number of participants who responded "Yes/No" to Question 1: Are you currently employed (working for pay)? are reported.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Baseline: Employed (n=183, 192)	57 participants	57 participants
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 16: Employed (n=169, 170)	57 participants	51 participants
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 17: Employed (n=167, 171)	58 participants	47 participants
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Baseline: Unemployed (n=183, 192)	126 participants	135 participants
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 16: Unemployed (n=169, 170)	112 participants	119 participants
Number of Participants Who Were Employed or Unemployed Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 17: Unemployed (n=167, 171)	109 participants	124 participants

SECONDARY outcome

Timeframe: Baseline, Week 16, 17

WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days. A participant who had responded 'no' to question 1 regarding employment status reported hours of work and as this was a self-reported questionnaire the source data were included.

Outcome measures

Outcome measures
Measure	Pregabalin n=58 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=58 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Baseline, Hours Missed,Leg/Foot Pain (n=57, 58)	5.58 hours Standard Deviation 10.601	4.86 hours Standard Deviation 11.488
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 16, Hours Missed,Leg/Foot Pain (n=57, 54)	2.05 hours Standard Deviation 5.044	2.41 hours Standard Deviation 6.603
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 17, Hours Missed,Leg/Foot Pain (n=58, 48)	3.03 hours Standard Deviation 5.364	1.27 hours Standard Deviation 2.703
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Baseline, Hours Missed,Other Reason (n=57, 58)	12.77 hours Standard Deviation 21.253	7.31 hours Standard Deviation 15.144
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 16, Hours Missed,Other Reason (n=57, 54)	7.53 hours Standard Deviation 15.121	6.74 hours Standard Deviation 14.070
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 17, Hours Missed,Other Reason (n=58, 48)	7.72 hours Standard Deviation 17.887	2.94 hours Standard Deviation 6.635
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Baseline: Hours Worked (n=57, 58)	32.54 hours Standard Deviation 17.367	28.76 hours Standard Deviation 18.780
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 16: Hours Worked (n=57, 54)	37.44 hours Standard Deviation 19.441	32.72 hours Standard Deviation 19.835
Absenteeism and Presenteeism Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 17: Hours Worked (n=58, 48)	34.83 hours Standard Deviation 20.670	38.15 hours Standard Deviation 21.399

SECONDARY outcome

Timeframe: Baseline, Week 16, 17

Population: ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.

WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired).

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 16: Productivity Affected (n=60, 54)	3.60 units on a scale Standard Deviation 2.402	3.15 units on a scale Standard Deviation 2.771
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 17: Daily Activity Affected (n=167, 171)	3.82 units on a scale Standard Deviation 2.568	3.64 units on a scale Standard Deviation 2.754
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Baseline: Productivity Affected (n=55, 57)	5.00 units on a scale Standard Deviation 2.480	5.93 units on a scale Standard Deviation 2.513
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 17: Productivity Affected (n=58, 48)	3.40 units on a scale Standard Deviation 2.615	3.00 units on a scale Standard Deviation 2.806
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Baseline: Daily Activity Affected (n=183, 192)	6.03 units on a scale Standard Deviation 2.078	6.12 units on a scale Standard Deviation 2.190
Productivity and Activity Impairment Assessed by Work Productivity and Activity Impairment: Specific Health Problem (WPAI: SHP) Questionnaire Week 16: Daily Activity Affected (n=169, 170)	3.75 units on a scale Standard Deviation 2.547	3.66 units on a scale Standard Deviation 2.769

SECONDARY outcome

Population: Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment. n = participants evaluable for this measure at specified time points for each arm group, respectively.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Body Weight Week 17 (n=167, 171)	73.6 kilogram Standard Deviation 18.13	72.6 kilogram Standard Deviation 16.95
Body Weight Screening (n=183, 192)	70.8 kilogram Standard Deviation 17.7	72.0 kilogram Standard Deviation 17.3
Body Weight Week 1 (n=183, 192)	71.2 kilogram Standard Deviation 17.76	72.5 kilogram Standard Deviation 17.84
Body Weight Week 4 (n=158, 169)	72.6 kilogram Standard Deviation 19.02	71.8 kilogram Standard Deviation 16.88
Body Weight Week 8 (n=146, 154)	73.1 kilogram Standard Deviation 19.35	72.1 kilogram Standard Deviation 17.17
Body Weight Week 12 (n=127, 137)	74.0 kilogram Standard Deviation 19.01	72.7 kilogram Standard Deviation 17.20
Body Weight Week 16 (n=170, 176)	73.6 kilogram Standard Deviation 18.06	72.5 kilogram Standard Deviation 17.00

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Week 1, 4, 8, 12, 16, 17

Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Sitting Systolic and Diastolic Blood Pressure Week 1: SBP (n=183, 192)	119.9 millimeter of mercury (mmHg) Standard Deviation 14.58	120.4 millimeter of mercury (mmHg) Standard Deviation 14.79
Sitting Systolic and Diastolic Blood Pressure Week 8: SBP (n=147, 154)	118.6 millimeter of mercury (mmHg) Standard Deviation 14.24	120.7 millimeter of mercury (mmHg) Standard Deviation 15.18
Sitting Systolic and Diastolic Blood Pressure Week 1: DBP (n=183, 192)	76.9 millimeter of mercury (mmHg) Standard Deviation 10.48	77.5 millimeter of mercury (mmHg) Standard Deviation 10.40
Sitting Systolic and Diastolic Blood Pressure Week 12: DBP (n=127, 137)	77.5 millimeter of mercury (mmHg) Standard Deviation 10.62	78.0 millimeter of mercury (mmHg) Standard Deviation 10.07
Sitting Systolic and Diastolic Blood Pressure Week 16: DBP (n=171, 176)	76.4 millimeter of mercury (mmHg) Standard Deviation 11.07	78.1 millimeter of mercury (mmHg) Standard Deviation 9.52
Sitting Systolic and Diastolic Blood Pressure Week 17: DBP (n=167, 171)	76.4 millimeter of mercury (mmHg) Standard Deviation 11.28	78.5 millimeter of mercury (mmHg) Standard Deviation 11.48
Sitting Systolic and Diastolic Blood Pressure Screening: SBP (n=183, 192)	121.2 millimeter of mercury (mmHg) Standard Deviation 16.18	122.1 millimeter of mercury (mmHg) Standard Deviation 15.02
Sitting Systolic and Diastolic Blood Pressure Week 4: SBP (n=159, 169)	117.9 millimeter of mercury (mmHg) Standard Deviation 16.42	119.8 millimeter of mercury (mmHg) Standard Deviation 15.07
Sitting Systolic and Diastolic Blood Pressure Week 12: SBP (n=127, 137)	120.2 millimeter of mercury (mmHg) Standard Deviation 15.33	121.7 millimeter of mercury (mmHg) Standard Deviation 14.30
Sitting Systolic and Diastolic Blood Pressure Week 16: SBP (n=171, 176)	119.3 millimeter of mercury (mmHg) Standard Deviation 15.71	122.9 millimeter of mercury (mmHg) Standard Deviation 13.67
Sitting Systolic and Diastolic Blood Pressure Week 17: SBP (n=167, 171)	120.1 millimeter of mercury (mmHg) Standard Deviation 15.89	121.6 millimeter of mercury (mmHg) Standard Deviation 14.35
Sitting Systolic and Diastolic Blood Pressure Screening: DBP (n=183, 192)	78.7 millimeter of mercury (mmHg) Standard Deviation 11.08	78.4 millimeter of mercury (mmHg) Standard Deviation 10.84
Sitting Systolic and Diastolic Blood Pressure Week 4: DBP (n=159, 169)	76.0 millimeter of mercury (mmHg) Standard Deviation 12.01	76.5 millimeter of mercury (mmHg) Standard Deviation 10.43
Sitting Systolic and Diastolic Blood Pressure Week 8: DBP (n=147, 154)	76.0 millimeter of mercury (mmHg) Standard Deviation 11.25	77.6 millimeter of mercury (mmHg) Standard Deviation 11.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Week 1, 4, 8, 12, 16, 17

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Sitting Heart Rate Week 16 (n=171, 176)	76.2 beats per minute (bpm) Standard Deviation 11.03	76.5 beats per minute (bpm) Standard Deviation 11.17
Sitting Heart Rate Week 17 (n=167, 171)	76.0 beats per minute (bpm) Standard Deviation 10.91	76.2 beats per minute (bpm) Standard Deviation 10.35
Sitting Heart Rate Screening (n=183, 192)	75.2 beats per minute (bpm) Standard Deviation 12.44	74.6 beats per minute (bpm) Standard Deviation 11.10
Sitting Heart Rate Week 1 (n=183, 192)	76.0 beats per minute (bpm) Standard Deviation 11.46	74.9 beats per minute (bpm) Standard Deviation 9.27
Sitting Heart Rate Week 4 (n=159, 169)	77.5 beats per minute (bpm) Standard Deviation 10.75	77.2 beats per minute (bpm) Standard Deviation 10.63
Sitting Heart Rate Week 8 (n=147, 154)	77.4 beats per minute (bpm) Standard Deviation 10.52	77.1 beats per minute (bpm) Standard Deviation 10.32
Sitting Heart Rate Week 12 (n=127, 137)	78.0 beats per minute (bpm) Standard Deviation 11.09	77.5 beats per minute (bpm) Standard Deviation 11.09

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

Population: Safety population included all participants who signed the informed consent, had exposure to study drug and had at least one safety assessment.

A neurological examination consisted of examination of the mental state, cranial nerve function, motor function (reflexes of patellar, achilles, biceps, babinski and coordination) and sensory function (sharp sensation of dorsal surface of right and left great toe, light touch of lower extremities \[LE\], right and left first metatarsal joint position sense, and vibration sensation \[vibration is felt for \< 6 seconds = markedly diminished, 6 to 10 seconds = mild loss, \> 10 seconds = normal\]).

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Number of Participants With Neurological Examination Findings Cranial Nerve Function: Abnormal	4 participants	0 participants
Number of Participants With Neurological Examination Findings Coordination, Gait: Missing	1 participants	1 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Patellar: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Patellar: Clonus (Very Intense)	0 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Achilles: Not Done	0 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Achilles: Hyperactive (More Brisk)	3 participants	1 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Achilles: Clonus (Very Intense)	0 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Achilles: None/Absent	90 participants	100 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Achilles: Hypoactive (Diminished)	75 participants	82 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Achilles: Hyperactive (More Brisk)	3 participants	1 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Achilles: Clonus (Very Intense)	0 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Biceps: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Biceps: None/Absent	1 participants	2 participants
Number of Participants With Neurological Examination Findings Sensory Function, Left Great Toe: Increased	14 participants	14 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Biceps: Normal	166 participants	178 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Biceps: Not Done	3 participants	2 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Biceps: Hyperactive (More Brisk)	4 participants	3 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Biceps: Clonus (Very Intense)	0 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Biceps: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Biceps: None/Absent	1 participants	2 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Biceps: Normal	169 participants	180 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Biceps: Not Done	2 participants	1 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Biceps: Hypoactive (Diminished)	7 participants	6 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Biceps: Clonus (Very Intense)	0 participants	0 participants
Number of Participants With Neurological Examination Findings Mental State: Missing	3 participants	0 participants
Number of Participants With Neurological Examination Findings Mental State: Normal	179 participants	192 participants
Number of Participants With Neurological Examination Findings Mental State: Abnormal	1 participants	0 participants
Number of Participants With Neurological Examination Findings Mental State: Not Done	0 participants	0 participants
Number of Participants With Neurological Examination Findings Sensory Function, Right Great Toe: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Sensory Function, Right Great Toe: Absent	63 participants	57 participants
Number of Participants With Neurological Examination Findings Sensory Function, Right Great Toe: Diminished	99 participants	114 participants
Number of Participants With Neurological Examination Findings Sensory Function, Right Great Toe: Normal	5 participants	7 participants
Number of Participants With Neurological Examination Findings Sensory Function, Right Great Toe: Increased	15 participants	14 participants
Number of Participants With Neurological Examination Findings Sensory Function, Left Great Toe: Absent	61 participants	58 participants
Number of Participants With Neurological Examination Findings Sensory Function, Left Great Toe: Diminished	102 participants	112 participants
Number of Participants With Neurological Examination Findings Sensory Function-Light Touch, LE: Hyposensitivity	99 participants	102 participants
Number of Participants With Neurological Examination Findings Sensory Function-Light Touch, LE: Normal Sensation	28 participants	25 participants
Number of Participants With Neurological Examination Findings Sensory Function-Light Touch, LE: Hypersensitivity	8 participants	8 participants
Number of Participants With Neurological Examination Findings Sensory Function, Right Metatarsal Sense: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Sensory Function, Right Metatarsal Sense: Abnormal	52 participants	47 participants
Number of Participants With Neurological Examination Findings Sensory Function, Right Metatarsal Sense: Not Done	1 participants	2 participants
Number of Participants With Neurological Examination Findings Sensory Function, Left Metatarsal Sense: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Sensory Function, Left Metatarsal Sense: Normal	129 participants	143 participants
Number of Participants With Neurological Examination Findings Sensory Function, Left Metatarsal Sense: Abnormal	51 participants	46 participants
Number of Participants With Neurological Examination Findings Vibration Sensation: Missing	2 participants	2 participants
Number of Participants With Neurological Examination Findings Vibration Sensation: Not Done	1 participants	1 participants
Number of Participants With Neurological Examination Findings Vibration Sensation: Markedly Diminished	42 participants	52 participants
Number of Participants With Neurological Examination Findings Vibration Sensation: Mild Loss	86 participants	79 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Babinski: Not Evaluable	3 participants	6 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Babinski: Absent	173 participants	180 participants
Number of Participants With Neurological Examination Findings Coordination, Romberg Test: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Achilles: Normal	14 participants	13 participants
Number of Participants With Neurological Examination Findings Cranial Nerve Function: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Cranial Nerve Function: Normal	178 participants	192 participants
Number of Participants With Neurological Examination Findings Cranial Nerve Function: Not Done	0 participants	0 participants
Number of Participants With Neurological Examination Findings Coordination, Gait: Normal	169 participants	181 participants
Number of Participants With Neurological Examination Findings Coordination, Gait: Not Evaluable	2 participants	2 participants
Number of Participants With Neurological Examination Findings Coordination, Gait: Mild Ataxia	7 participants	7 participants
Number of Participants With Neurological Examination Findings Coordination, Gait: Moderate Ataxia	3 participants	1 participants
Number of Participants With Neurological Examination Findings Coordination, Gait: Severe Ataxia	1 participants	0 participants
Number of Participants With Neurological Examination Findings Coordination, Romberg Test: Normal	174 participants	188 participants
Number of Participants With Neurological Examination Findings Coordination, Romberg Test: Abnormal	6 participants	2 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Babinski: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Achilles: Hypoactive (Diminished)	73 participants	78 participants
Number of Participants With Neurological Examination Findings Coordination, Romberg Test: Not Done	2 participants	2 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Patellar: None/Absent	7 participants	13 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Patellar: Normal	124 participants	130 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Patellar: Not Done	0 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Patellar: Hypoactive (Diminished)	43 participants	41 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Patellar: Hyperactive (More Brisk)	8 participants	8 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Patellar: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Patellar: None/Absent	8 participants	13 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Patellar: Normal	124 participants	129 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Patellar: Not Done	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Patellar: Hypoactive (Diminished)	42 participants	41 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Patellar: Hyperactive (More Brisk)	7 participants	9 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Patellar: Clonus (Very Intense)	0 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Achilles: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Achilles: None/Absent	92 participants	100 participants
Number of Participants With Neurological Examination Findings Vibration Sensation: Normal	25 participants	34 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Babinski: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Babinski: Not Evaluable	3 participants	6 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Babinski: Absent	173 participants	180 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Babinski: Present	6 participants	6 participants
Number of Participants With Neurological Examination Findings Sensory Function, Left Great Toe: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Sensory Function, Left Great Toe: Normal	5 participants	8 participants
Number of Participants With Neurological Examination Findings Sensory Function-Light Touch, LE: Missing	2 participants	3 participants
Number of Participants With Neurological Examination Findings Sensory Function-Light Touch, LE: Not Done	7 participants	6 participants
Number of Participants With Neurological Examination Findings Sensory Function-Light Touch, LE: Unable to Detect	39 participants	48 participants
Number of Participants With Neurological Examination Findings Sensory Function, Right Metatarsal Sense: Normal	129 participants	143 participants
Number of Participants With Neurological Examination Findings Sensory Function, Left Metatarsal Sense: Not Done	2 participants	3 participants
Number of Participants With Neurological Examination Findings Vibration Sensation: Absent	27 participants	24 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Babinski: Present	6 participants	6 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Achilles: Missing	1 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Achilles: Normal	14 participants	9 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Achilles: Not Done	0 participants	0 participants
Number of Participants With Neurological Examination Findings Reflexes, Right Biceps: Hypoactive (Diminished)	8 participants	7 participants
Number of Participants With Neurological Examination Findings Reflexes, Left Biceps: Hyperactive (More Brisk)	3 participants	3 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

Population: Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.

MINI: short structured clinical interview to make diagnoses of psychiatric disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or International Classifications of Disease-10 (ICD-10). In the MINI Modules, participants were asked a series of Yes/No questions.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening, Post-Baseline (Week 4 up to Week 17)

S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories Screening: SI BHV, no Su intent (n=183, 192)	4 participants	4 participants
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories Screening: Preparatory Acts (n=183, 192)	5 participants	8 participants
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories Screening: Su ID (n=183, 192)	28 participants	37 participants
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories Post-Baseline: Su Attempt (n=178, 185)	0 participants	1 participants
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories Post-Baseline: Preparatory Acts (n=178, 185)	0 participants	2 participants
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories Post-Baseline: Su ID (n=178, 185)	5 participants	11 participants
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories Post-Baseline: SI BHV, no Su intent (n=178, 185)	0 participants	0 participants
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories Screening: Su Attempt (n=183, 192)	5 participants	8 participants
Number of Participants With Response to Sheehan-Suicidality Tracking Scale (S-STS) Mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories Post-Baseline: Completed Suicide (n=178, 185)	0 participants	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

Population: ITT population: all randomized participants who took at least 1 dose of study drug. n = participants evaluable for this measure at specified time points for each arm group, respectively.

PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated "Over past 2 weeks, how often bothered by any of following problems?": little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual (8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity.

Outcome measures

Outcome measures
Measure	Pregabalin n=183 Participants Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 Participants Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Move-Speak Slow/Fidgety:Nearly Everyday(n=183,192)	6 participants	6 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Trouble Concentrating: > 1/2 Days (n=183, 192)	11 participants	13 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Tired: Several Days (n=183, 192)	87 participants	100 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Little Interest: Not at All (n=183, 192)	77 participants	89 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Little Interest: > 1/2 Days (n=183,192)	23 participants	20 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Little Interest: Several Days (n=183, 192)	63 participants	72 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Little Interest: Nearly Every Day (n=183, 192)	20 participants	11 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Down: Not at All (n=183, 192)	105 participants	109 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Down: Several Days (n=183, 192)	61 participants	59 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Down: > 1/2 Days the Days (n=183, 192)	13 participants	12 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Down: Nearly Every Day (n=183, 192)	4 participants	12 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Trouble With Sleep: Not at All (n=182, 192)	63 participants	68 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Trouble With Sleep: Several Days (n=182, 192)	69 participants	86 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Trouble With Sleep: > 1/2 Days (n=182, 192)	26 participants	22 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Trouble With Sleep: Nearly Every Day (n=182, 192)	24 participants	16 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Tired: Not at All (n=183, 192)	57 participants	56 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Tired: > 1/2 Days (n=183, 192)	27 participants	29 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Tired: Nearly Every Day (n=183, 192)	12 participants	7 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Poor Appetite/Overeat: Not at All (n=183, 192)	99 participants	116 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Poor Appetite/Overeat: Several Days (n=183, 192)	53 participants	56 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Poor Appetite/Overeat: > 1/2 Days (n=183, 192)	21 participants	15 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Poor Appetite/Overeat: Nearly Everyday (n=183,192)	10 participants	5 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Bad About Self: Not at All (n=183, 192)	124 participants	138 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Bad About Self: Several Days (n=183, 192)	41 participants	43 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Bad About Self: > 1/2 Days (n=183, 192)	12 participants	6 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Feeling Bad About Self: Nearly Everyday(n=183,192)	6 participants	5 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Trouble Concentrating: Not at All (n=183, 192)	131 participants	140 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Trouble Concentrating: Several Days (n=183, 192)	35 participants	33 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Trouble Concentrating: Nearly Everyday (n=183,192)	6 participants	6 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Move-Speak Slow/Fidgety: >1/2 Days (n=183, 192)	10 participants	10 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Move-Speak Slow/Fidgety: Not at All (n=183,192)	144 participants	143 participants
Number of Participants With Response to Patient Health Questionnaire-8 (PHQ-8) Move-Speak Slow/Fidgety:Several Days(n=183,192)	23 participants	33 participants

Adverse Events

Pregabalin

Serious events: 7 serious events

Other events: 64 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Pregabalin n=183 participants at risk Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 participants at risk Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Infections and infestations Influenza	9.3% 17/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.2% 12/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	13.7% 25/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.2% 10/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	13.7% 25/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.5% 26/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	7.1% 13/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.1% 4/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

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

Measure	Pregabalin n=183 participants at risk Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.	Placebo n=192 participants at risk Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
Gastrointestinal disorders Diarrhoea	0.55% 1/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Perineal abscess	0.55% 1/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.55% 1/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.00% 0/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Demyelinating polyneuropathy	0.55% 1/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Loss of consciousness	0.55% 1/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Peripheral sensorimotor neuropathy	0.55% 1/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	0.55% 1/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure acute	0.55% 1/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/183 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.52% 1/192 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.