Trial Outcomes & Findings for A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression (NCT NCT01432236)

Last Updated: 2021-01-22

Results Overview

The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

197 participants

Primary outcome timeframe

End of each period, at Weeks 6 and 14

Results posted on

2021-01-22

Participant Flow

In this double blind, crossover study, a total of 197 participants were randomized to either pregabalin/placebo or placebo/pregabalin treatment sequence. Of these, 193 took at least one dose of study medication. Four randomized participants never took study medication. Randomized participants were recruited from 4 countries at 38 study centers.

Participants with mean Numeric Rating Scale (NRS) pain score of ≥4 at Baseline and meeting all other inclusion/exclusion criteria were randomly assigned to receive double blind treatment with either pregabalin followed by placebo with background antidepressant or placebo followed by pregabalin with background antidepressant.

Participant milestones

Participant milestones
Measure	Pregabalin/Placebo Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo/Pregabalin Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
Overall Study STARTED	96	97
Overall Study COMPLETED	70	79
Overall Study NOT COMPLETED	26	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin/Placebo n=96 Participants Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo/Pregabalin n=97 Participants Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Total n=193 Participants Total of all reporting groups
Age, Customized < 18 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 18-44 Years	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Age, Customized 45-64 Years	69 Participants n=5 Participants	60 Participants n=7 Participants	129 Participants n=5 Participants
Age, Customized >= 65 Years	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	93 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

Outcome measures

Outcome measures
Measure	Pregabalin n=179 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=173 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Mean NRS Pain Score at End of Period.	4.84 Units on a scale Standard Error 0.15	5.45 Units on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).

Outcome measures

Outcome measures
Measure	Pregabalin n=96 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=97 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Total (N=96, 96)	63.83 Units on a scale Standard Deviation 11.58	62.75 Units on a scale Standard Deviation 12.51
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Physical Impairment (N=96, 97)	4.58 Units on a scale Standard Deviation 2.10	4.44 Units on a scale Standard Deviation 2.14
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Feel Good (N=96, 97)	7.78 Units on a scale Standard Deviation 2.47	7.43 Units on a scale Standard Deviation 2.32
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Work Missed (N=96, 97)	3.38 Units on a scale Standard Deviation 2.88	3.49 Units on a scale Standard Deviation 3.21
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Do Work (N=96, 97)	6.61 Units on a scale Standard Deviation 2.03	6.38 Units on a scale Standard Deviation 2.21
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Pain (N=96, 96)	6.98 Units on a scale Standard Deviation 1.25	7.09 Units on a scale Standard Deviation 1.32
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Fatigue (N=96, 97)	8.17 Units on a scale Standard Deviation 1.37	8.08 Units on a scale Standard Deviation 1.58
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Rested (N=96, 97)	7.90 Units on a scale Standard Deviation 1.51	7.82 Units on a scale Standard Deviation 1.96
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Stiffness (N=96, 97)	7.56 Units on a scale Standard Deviation 1.76	7.64 Units on a scale Standard Deviation 1.58
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Anxiety (N=96, 97)	5.65 Units on a scale Standard Deviation 2.73	5.60 Units on a scale Standard Deviation 2.59
Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline. Depression (N=96, 97)	5.23 Units on a scale Standard Deviation 2.64	4.84 Units on a scale Standard Deviation 2.55

SECONDARY outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. Different number (N) for each category represents participants that were actually treated with pregabalin and placebo during the study.

Outcome measures

Outcome measures
Measure	Pregabalin n=181 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=177 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
FIQ Score at End of Period. Total (N=176, 172)	43.78 Units on a scale Standard Error 1.42	50.38 Units on a scale Standard Error 1.43
FIQ Score at End of Period. Physical impairment (N=176, 173)	3.35 Units on a scale Standard Error 0.17	3.77 Units on a scale Standard Error 0.17
FIQ Score at End of Period. Feel good (N=176, 173)	4.69 Units on a scale Standard Error 0.23	5.53 Units on a scale Standard Error 0.23
FIQ Score at End of Period. Work missed (N=176 , 173)	2.02 Units on a scale Standard Error 0.21	2.62 Units on a scale Standard Error 0.21
FIQ Score at End of Period. Do work (N=176, 172)	4.56 Units on a scale Standard Error 0.20	5.31 Units on a scale Standard Error 0.20
FIQ Score at End of Period. Pain (N=176, 173)	4.91 Units on a scale Standard Error 0.17	5.54 Units on a scale Standard Error 0.17
FIQ Score at End of Period. Fatigue (N=176, 173)	6.32 Units on a scale Standard Error 0.19	6.76 Units on a scale Standard Error 0.19
FIQ Score at End of Period. Rested (N=176, 173)	5.64 Units on a scale Standard Error 0.19	6.41 Units on a scale Standard Error 0.19
FIQ Score at End of Period. Stiffness (N=176, 173)	5.24 Units on a scale Standard Error 0.19	5.95 Units on a scale Standard Error 0.19
FIQ Score at End of Period. Anxiety (N=176, 173)	3.80 Units on a scale Standard Error 0.20	4.35 Units on a scale Standard Error 0.21
FIQ Score at End of Period. Depression (N=176, 173)	3.20 Units on a scale Standard Error 0.20	4.13 Units on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: End of Period 1 at Week 6

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

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

Outcome measures

Outcome measures
Measure	Pregabalin n=93 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=93 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Patient Global Impression of Change (PGIC) at the End of Period 1. Very much improved	10.8 Percentage of participants	4.3 Percentage of participants
Patient Global Impression of Change (PGIC) at the End of Period 1. Much improved	35.5 Percentage of participants	25.8 Percentage of participants
Patient Global Impression of Change (PGIC) at the End of Period 1. Minimally improved	28.0 Percentage of participants	40.9 Percentage of participants
Patient Global Impression of Change (PGIC) at the End of Period 1. No change	17.2 Percentage of participants	21.5 Percentage of participants
Patient Global Impression of Change (PGIC) at the End of Period 1. Minimally worse	4.3 Percentage of participants	6.5 Percentage of participants
Patient Global Impression of Change (PGIC) at the End of Period 1. Much worse	3.2 Percentage of participants	1.1 Percentage of participants
Patient Global Impression of Change (PGIC) at the End of Period 1. Very much worse	1.1 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Visits 2, 6, and 12

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

Participant with at least a 30% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 30% responder, for the respective period. Similarly, a subject with at least a 50% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 50% responder, for the respective period.

Outcome measures

Outcome measures
Measure	Pregabalin n=179 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=173 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary. 30% Responders	45.3 Percentage of participants	27.7 Percentage of participants
Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary. 50% Responders	26.0 Percentage of participants	15.8 Percentage of participants

SECONDARY outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

Subjective Sleep Questionnaire included 5 items: participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective rating of quality of sleep during the past night was done by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses was therefore 0-10.

Outcome measures

Outcome measures
Measure	Pregabalin n=179 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=173 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.	6.15 Units on a scale Standard Error 0.14	5.57 Units on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective wake after sleep onset was the subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening.

Outcome measures

Outcome measures
Measure	Pregabalin n=179 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=173 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.	33.38 Minutes Standard Error 2.73	41.18 Minutes Standard Error 2.76

SECONDARY outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective latency to sleep onset was the subjective estimate of the amount of time to fall asleep after lights out.

Outcome measures

Outcome measures
Measure	Pregabalin n=179 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=173 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.	33.54 Minutes Standard Error 2.68	39.33 Minutes Standard Error 2.71

SECONDARY outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.

Outcome measures

Outcome measures
Measure	Pregabalin n=179 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=173 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.	422.98 Minutes Standard Error 5.42	414.63 Minutes Standard Error 5.48

SECONDARY outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective number of awakenings after sleep onset was the subjective estimate of the total number of times the participant awakened during the night until final awakening.

Outcome measures

Outcome measures
Measure	Pregabalin n=179 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=173 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.	0.48 Number of times awakened Standard Error 0.07	0.61 Number of times awakened Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

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

Outcome measures

Outcome measures
Measure	Pregabalin n=96 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=97 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Hospital Anxiety and Depression Scale (HADS) at Baseline. HADS-A (anxiety)	8.67 Units on a scale Standard Deviation 3.95	7.97 Units on a scale Standard Deviation 3.77
Hospital Anxiety and Depression Scale (HADS) at Baseline. HADS-D (depression)	8.34 Units on a scale Standard Deviation 3.59	7.73 Units on a scale Standard Deviation 3.64

SECONDARY outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

Outcome measures

Outcome measures
Measure	Pregabalin n=176 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=173 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
HADS at End of Period. HADS-A (anxiety)	6.01 Units on a scale Standard Error 0.28	6.96 Units on a scale Standard Error 0.28
HADS at End of Period. HADS-D (depression)	6.17 Units on a scale Standard Error 0.31	7.05 Units on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).

Outcome measures

Outcome measures
Measure	Pregabalin n=96 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=97 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.	0.40 Units on a scale Standard Deviation 0.31	0.37 Units on a scale Standard Deviation 0.33

SECONDARY outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

Outcome measures

Outcome measures
Measure	Pregabalin n=176 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=172 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
EQ-5D Score at End of Period.	0.58 Units on a scale Standard Error 0.02	0.56 Units on a scale Standard Error 0.02

OTHER_PRE_SPECIFIED outcome

Timeframe: End of Period 2 at Week 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

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). Because of the crossover design and PGIC recall period (since starting study medication), the Period 1 PGIC data were felt to provide the clearest comparison across treatments, whereas Period 2 PGIC data were felt to have a more complex interpretation. Thus PGIC at End of Period 2 was separately analyzed from PGIC at End of Period 1.

Outcome measures

Outcome measures
Measure	Pregabalin n=82 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=81 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
PGIC at the End of Period 2. Very much improved	18.3 Percentage of Participants	8.6 Percentage of Participants
PGIC at the End of Period 2. Much improved	34.1 Percentage of Participants	25.9 Percentage of Participants
PGIC at the End of Period 2. Minimally improved	28.0 Percentage of Participants	38.3 Percentage of Participants
PGIC at the End of Period 2. No change	11.0 Percentage of Participants	14.8 Percentage of Participants
PGIC at the End of Period 2. Much worse	1.2 Percentage of Participants	2.5 Percentage of Participants
PGIC at the End of Period 2. Very much worse	1.2 Percentage of Participants	1.2 Percentage of Participants
PGIC at the End of Period 2. Minimally worse	6.1 Percentage of Participants	8.6 Percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

PSGA was a single-item self-rated instrument that measured the participant's overall status on an 11-point NRS ranging from 0 (very poor) to 10 (very good).

Outcome measures

Outcome measures
Measure	Pregabalin n=96 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=97 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Mean Patient Static Global Assessment (PSGA) Score at Baseline.	4.35 Units on a scale Standard Deviation 2.04	4.46 Units on a scale Standard Deviation 1.92

OTHER_PRE_SPECIFIED outcome

Timeframe: End of each period, at Weeks 6 and 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

PSGA was a single-item self-rated instrument that measured the participant's overall status on an 11-point numeric rating scale (NRS) ranging from 0 (very poor) to 10 (very good).

Outcome measures

Outcome measures
Measure	Pregabalin n=176 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=172 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Mean PSGA Score at End of Period.	5.83 Units on a scale Standard Error 0.17	5.27 Units on a scale Standard Error 0.17

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) ("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").

Outcome measures

Outcome measures
Measure	Pregabalin n=96 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=97 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Completed Suicide	0 Participants	0 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Wish to be Dead	3 Participants	1 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Non-Specific Thoughts	0 Participants	1 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Without Intent to Act	0 Participants	0 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Some Intent to Act	0 Participants	0 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Specific Plan and Intent	0 Participants	0 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Actual Attempt	0 Participants	0 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Non-Suicidal Self-Injurious Behavior	0 Participants	0 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Interrupted Attempt	0 Participants	0 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Aborted Attempt	0 Participants	0 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Preparatory Acts or Behavior	0 Participants	0 Participants
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline. Suicidal Behavior Present	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From Visit 3 to Visit 14

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

C-SSRS assessed whether participant experienced following:completed suicide (1), suicide attempt (2) (response of Yes on "actual attempt"), preparatory acts toward imminent suicidal behavior (3) (Yes on "preparatory acts or behavior"), suicidal ideation (4) (Yes on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on "Has subject engaged in non-suicidal self-injurious behavior"). Below table indicated one participant (10141023) treated with Pregabalin reported preparatory act. However upon study unblinding it was clarified that preparatory act occurred while the participant was taking placebo. Since preparatory act was reported at first visit of Period 2, by convention statistical summaries classified this under Pregabalin treatment.

Outcome measures

Outcome measures
Measure	Pregabalin n=181 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=177 Participants The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Wish to be Dead	10 Participants	8 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Non-Specific Thoughts	3 Participants	1 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Without Intent to Act	2 Participants	0 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Some Intent to Act	0 Participants	0 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Specific Plan and Intent	0 Participants	0 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Actual Attempt	0 Participants	0 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Non-Suicidal Self-Injurious Behavior	0 Participants	0 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Interrupted Attempt	0 Participants	0 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Aborted Attempt	0 Participants	0 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Preparatory Acts or Behavior	1 Participants	0 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Suicidal Behavior Present	1 Participants	0 Participants
Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline. Completed Suicide	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

WPAI-SHP assessed work productivity and impairment. It was a participant-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past 7 days. Subscale scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Each subscale score was expressed as an impairment percentage (0-100) where higher numbers indicated greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Pregabalin n=193 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline. Percent Absenteeism (N= 86)	15.22 Units on a scale Standard Deviation 25.36	—
Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline. Percent Presenteeism (N= 83)	53.98 Units on a scale Standard Deviation 21.52	—
Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline. Percent Overall Work Impairment (N= 82)	57.96 Units on a scale Standard Deviation 23.42	—
Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline. Percent Activity Impairment (N=193)	64.97 Units on a scale Standard Deviation 18.77	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services.

Outcome measures

Outcome measures
Measure	Pregabalin n=193 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Health Utilization Assessment (Total Office Visits, Number of Hospitalizations and Number of Emergency Room Visits) at Baseline. Total office visits (N= 193)	5.01 Visits Standard Deviation 6.6	—
Health Utilization Assessment (Total Office Visits, Number of Hospitalizations and Number of Emergency Room Visits) at Baseline. Number of hospitalizations (N= 0)	NA Visits Standard Deviation NA Could not be calculated as N=0	—
Health Utilization Assessment (Total Office Visits, Number of Hospitalizations and Number of Emergency Room Visits) at Baseline. Number of emergency room visits (N= 12)	1.83 Visits Standard Deviation 1.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.

The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services. 'Time for help no payment' refers to time other people spent without receiving payment to help with activities the patient cannot perform due to fibromyalgia.

Outcome measures

Outcome measures
Measure	Pregabalin n=193 Participants The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Health Utilization Assessment (Time for Help no Payment) at Baseline.	50.37 Hours Standard Deviation 98.1	—

Adverse Events

Pregabalin

Serious events: 3 serious events

Other events: 139 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 106 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pregabalin n=181 participants at risk The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.	Placebo n=177 participants at risk The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
Musculoskeletal and connective tissue disorders Pain in extremity	0.55% 1/181 • Up to Week 16 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% 0/177 • Up to Week 16 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) Brain neoplasm malignant	0.00% 0/181 • Up to Week 16 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.	0.56% 1/177 • Up to Week 16 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 Anxiety	0.55% 1/181 • Up to Week 16 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% 0/177 • Up to Week 16 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.
Surgical and medical procedures Detoxification	0.55% 1/181 • Up to Week 16 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% 0/177 • Up to Week 16 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.

Other adverse events

Additional Information

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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.
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