Trial Outcomes & Findings for Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia (NCT NCT00883740)
NCT ID: NCT00883740
Last Updated: 2021-01-25
Results Overview
WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography \[PSG\]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording \[i.e. awake epoch immediately prior to the end of the recording\]) on 2 consecutive nights divided by 2 at the end of each intervention period.
COMPLETED
PHASE3
119 participants
Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)
2021-01-25
Participant Flow
Participant milestones
| Measure |
Placebo, Then Pregabalin
Matching placebo twice daily in first intervention (treatment period 1, weeks 1-4) and pregabalin 75 milligrams (mg) up to 225 mg twice per day in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
|
Pregabalin, Then Placebo
Pregabalin 75 mg up to 225 mg twice per day in intervention (treatment period 1, weeks 1-4) and matching placebo twice daily in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
|
|---|---|---|
|
First Intervention
STARTED
|
60
|
59
|
|
First Intervention
COMPLETED
|
53
|
51
|
|
First Intervention
NOT COMPLETED
|
7
|
8
|
|
Taper and Washout Period (2 Weeks)
STARTED
|
54
|
51
|
|
Taper and Washout Period (2 Weeks)
COMPLETED
|
54
|
51
|
|
Taper and Washout Period (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
53
|
51
|
|
Second Intervention
COMPLETED
|
52
|
50
|
|
Second Intervention
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo, Then Pregabalin
Matching placebo twice daily in first intervention (treatment period 1, weeks 1-4) and pregabalin 75 milligrams (mg) up to 225 mg twice per day in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
|
Pregabalin, Then Placebo
Pregabalin 75 mg up to 225 mg twice per day in intervention (treatment period 1, weeks 1-4) and matching placebo twice daily in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
|
|---|---|---|
|
First Intervention
Lost to Follow-up
|
1
|
0
|
|
First Intervention
No longer willing to participate
|
2
|
0
|
|
First Intervention
Protocol Violation
|
3
|
6
|
|
First Intervention
Adverse Event
|
1
|
2
|
|
Second Intervention
Protocol Violation
|
1
|
0
|
|
Second Intervention
No longer willing to participate
|
0
|
1
|
Baseline Characteristics
Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=119 Participants
Includes groups randomized to receive matching placebo and Pregabalin, 75 up to 225 mg, twice per day in the first intervention and Pregabalin, 75 up to 225 mg, and matching placebo twice per day in the second intervention
|
|---|---|
|
Age, Continuous
|
48.4 Years
STANDARD_DEVIATION 9.9 • n=39 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
|
Medical Outcome Study Sleep Scale (MOS-SS) Sleep Disturbance Baseline Measure (Weeks 1 and 7)
Week 1 Sleep Disturbance Placebo
|
69.32 Scores on a Scale
STANDARD_DEVIATION 17.48 • n=39 Participants
|
|
Medical Outcome Study Sleep Scale (MOS-SS) Sleep Disturbance Baseline Measure (Weeks 1 and 7)
Week 1 Sleep Disturbance Pregabalin
|
69.29 Scores on a Scale
STANDARD_DEVIATION 20.44 • n=39 Participants
|
|
Medical Outcome Study Sleep Scale (MOS-SS) Sleep Disturbance Baseline Measure (Weeks 1 and 7)
Week 7 Sleep Disturbance Placebo
|
52.75 Scores on a Scale
STANDARD_DEVIATION 24.77 • n=39 Participants
|
|
Medical Outcome Study Sleep Scale (MOS-SS) Sleep Disturbance Baseline Measure (Weeks 1 and 7)
Week 7 Sleep Disturbance Pregabalin
|
51.51 Scores on a Scale
STANDARD_DEVIATION 26.48 • n=39 Participants
|
|
MOS-SS Overall Sleep Index II Baseline Measure (Weeks 1 and 7)
Week 1 Sleep Problems Index II Placebo
|
62.82 Scores on a Scale
STANDARD_DEVIATION 12.96 • n=39 Participants
|
|
MOS-SS Overall Sleep Index II Baseline Measure (Weeks 1 and 7)
Week 1 Sleep Problems Index II Pregabalin
|
63.21 Scores on a Scale
STANDARD_DEVIATION 14.27 • n=39 Participants
|
|
MOS-SS Overall Sleep Index II Baseline Measure (Weeks 1 and 7)
Week 7 Sleep Problems Index II Placebo
|
47.22 Scores on a Scale
STANDARD_DEVIATION 18.38 • n=39 Participants
|
|
MOS-SS Overall Sleep Index II Baseline Measure (Weeks 1 and 7)
Week 7 Sleep Problems Index II Pregablin
|
48.79 Scores on a Scale
STANDARD_DEVIATION 19.89 • n=39 Participants
|
PRIMARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)Population: Per Protocol Population (PP) = all randomized participants who received study medication at a dose of 300 or 450 mg/day and completed the study without any major protocol violations;
WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography \[PSG\]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording \[i.e. awake epoch immediately prior to the end of the recording\]) on 2 consecutive nights divided by 2 at the end of each intervention period.
Outcome measures
| Measure |
Placebo
n=83 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=83 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Wake After Sleep Onset (WASO) at Weeks 5 and 11
|
70.69 Minutes
Standard Error 3.78
|
51.54 Minutes
Standard Error 3.78
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: Intent to treat (ITT) population: randomized participants who received at least one dose of medication and had at least one efficacy evaluation
WTDS, as determined by PSG, was the total amount of time awake the participant experienced after the onset of persistent sleep and prior to the final awakening, or at the end of 8 hours of recording. WTDS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Wake Time During Sleep (WTDS)
|
63.38 Minutes
Standard Error 2.90
|
45.83 Minutes
Standard Error 2.93
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
WTAS, as determined by PSG, was the total amount of time awake after the final awakening until the end of the 8 hours. WTAS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Wake Time After Sleep (WTAS)
|
9.19 Minutes
Standard Error 1.55
|
7.38 Minutes
Standard Error 1.57
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
TST, as determined by PSG, was the number of non-wake epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Total Sleep Time (TST)
|
370.6 Minutes
Standard Error 4.65
|
396.2 Minutes
Standard Error 4.69
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
SE, as determined by PSG, was the TST divided by the time in bed, multiplied by 100. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Sleep Efficiency (SE)
|
77.21 Percentage of time asleep
Standard Error 0.97
|
82.64 Percentage of time asleep
Standard Error 0.98
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
NAASO 1, as determined by PSG, was the number of times there was a wake period of at least one epoch in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage rapid eye movement (REM) epoch. The sum of 2 consecutive nights of recording was divided by 2 at the end of each intervention period.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Number of Awakenings After Sleep Onset (NAASO 1)
|
26.92 Awakenings
Standard Error 1.00
|
24.51 Awakenings
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
NAASO 2, as determined by PSG, was the number of times that there was a wake period of at least two epochs in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage REM epoch. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Number of Awakenings After Sleep Onset (NAASO 2)
|
10.16 Awakenings
Standard Error 0.44
|
8.63 Awakenings
Standard Error 0.45
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
LPS, as determined by PSG, was the total number of epochs recorded on 2 consecutive nights divided by 2 at the end of each intervention period, from the beginning of the recording to the start of the first 20 consecutive non-wake epochs.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Latency to Persistent Sleep (LPS)
|
41.63 Minutes
Standard Error 3.70
|
34.45 Minutes
Standard Error 3.74
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
WASO, as determined by PSG, was the wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual hour (8 hours total).
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
WASO by Hour of the Night
Hour 1
|
1.96 Minutes
Standard Error 0.27
|
1.62 Minutes
Standard Error 0.28
|
|
WASO by Hour of the Night
Hour 2
|
5.66 Minutes
Standard Error 0.52
|
4.56 Minutes
Standard Error 0.53
|
|
WASO by Hour of the Night
Hour 3
|
7.09 Minutes
Standard Error 0.54
|
4.65 Minutes
Standard Error 0.55
|
|
WASO by Hour of the Night
Hour 4
|
8.95 Minutes
Standard Error 0.75
|
5.43 Minutes
Standard Error 0.75
|
|
WASO by Hour of the Night
Hour 5
|
10.55 Minutes
Standard Error 0.90
|
7.54 Minutes
Standard Error 0.90
|
|
WASO by Hour of the Night
Hour 6
|
11.26 Minutes
Standard Error 0.94
|
7.38 Minutes
Standard Error 0.95
|
|
WASO by Hour of the Night
Hour 7
|
10.96 Minutes
Standard Error 0.91
|
8.38 Minutes
Standard Error 0.92
|
|
WASO by Hour of the Night
Hour 8
|
17.08 Minutes
Standard Error 1.34
|
14.23 Minutes
Standard Error 1.35
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
WASO, as determined by PSG, was the sum of wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual quarter of the night (eight hours in 2 hour increments).
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
WASO by Each Quarter of the Night
Quarter 3
|
21.73 Minutes
Standard Error 1.58
|
14.90 Minutes
Standard Error 1.60
|
|
WASO by Each Quarter of the Night
Quarter 1
|
7.23 Minutes
Standard Error 0.63
|
5.98 Minutes
Standard Error 0.64
|
|
WASO by Each Quarter of the Night
Quarter 2
|
16.04 Minutes
Standard Error 1.05
|
10.04 Minutes
Standard Error 1.06
|
|
WASO by Each Quarter of the Night
Quarter 4
|
28.04 Minutes
Standard Error 1.98
|
22.60 Minutes
Standard Error 2.00
|
SECONDARY outcome
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
SWS, as determined by PSG, Stage 3 plus 4 sleep divided by TST times 100 was the percentage of TST. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Slow Wave Sleep (SWS)
|
15.04 Percentage of total sleep time
Standard Error 1.01
|
17.18 Percentage of total sleep time
Standard Error 1.01
|
SECONDARY outcome
Timeframe: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT; n: number of participants at specific time points
MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was comprised of 12 items yielding 7 subscale scores and 2 index composite index scores. Sleep Disturbance subscale score (4 items): individual scores were transformed (actual raw score minus lowest possible score divided by possible raw score range times 100) and ranged from 0 to 100; higher score indicated greater disturbance. Total score ranged=0 to 100; higher score indicates greater intensity of attribute. Change was score at week x minus score at baseline.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11
Change Week 1 to Week 5 (n=59, 56)
|
-19.0 Units on a scale
Standard Error 2.98
|
-27.1 Units on a scale
Standard Error 3.06
|
|
Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11
Change Week 7 to Week 11 (n=50, 52)
|
-2.23 Units on a scale
Standard Error 3.10
|
-21.0 Units on a scale
Standard Error 3.04
|
SECONDARY outcome
Timeframe: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ETPopulation: ITT
MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was compromised of 12 items yielding 7 subscale scores and 2 index composite index scores. Composite index included Sleep Problems Index II (9 items), scores ranged from 0 to 100; higher scores indicated greater sleep problems. Change was score at week x minus score at baseline.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11
Change Week 1 to Week 5 (n=59, 56)
|
-16.4 Units on a scale
Standard Error 2.37
|
-21.9 Units on a scale
Standard Error 2.43
|
|
Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11
Change Week 7 to Week 11 (50, 52)
|
-0.98 Units on a scale
Standard Error 2.51
|
-14.4 Units on a scale
Standard Error 2.46
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ETPopulation: ITT; Last observation carried forward (LOCF)
Sleep Quality as meassured by numeric rating scale (NRS), a participant rated scale 0 to 10, (0 = very poor sleep, 10 = excellent sleep). Weekly values were calculated as the average of the participants daily diary scores.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Sleep Quality
Week 3
|
5.09 Unit on a scale
Standard Error 0.17
|
5.96 Unit on a scale
Standard Error 0.17
|
|
Sleep Quality
Week 4
|
5.17 Unit on a scale
Standard Error 0.17
|
6.06 Unit on a scale
Standard Error 0.17
|
|
Sleep Quality
Week 1
|
4.79 Unit on a scale
Standard Error 0.16
|
5.70 Unit on a scale
Standard Error 0.17
|
|
Sleep Quality
Week 2
|
4.95 Unit on a scale
Standard Error 0.18
|
6.09 Unit on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ETPopulation: ITT; LOCF
LSO as reported on daily Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the amount of time to fall asleep after lights out. Weekly values were calculated as the average minutes reported on the participant's daily SSQ.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Latency of Sleep Onset (LSO)
Week 1
|
51.23 Minutes
Standard Error 2.61
|
43.56 Minutes
Standard Error 2.61
|
|
Latency of Sleep Onset (LSO)
Week 3
|
48.92 Minutes
Standard Error 4.01
|
43.24 Minutes
Standard Error 4.02
|
|
Latency of Sleep Onset (LSO)
Week 2
|
49.94 Minutes
Standard Error 2.92
|
42.27 Minutes
Standard Error 2.92
|
|
Latency of Sleep Onset (LSO)
Week 4
|
46.70 Minutes
Standard Error 2.68
|
40.51 Minutes
Standard Error 2.68
|
SECONDARY outcome
Timeframe: Daily up to Day 73 or ETPopulation: ITT; LOCF
Pain intensity as measured by NRS; a participant rated scale 0 to 10 (0 = no pain to 10 = worst pain possible). Weekly values were calculated as the average of the participants daily pain scores.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Daily Pain Score
Week 2
|
5.81 Units on a scale
Standard Error 0.18
|
5.10 Units on a scale
Standard Error 0.18
|
|
Daily Pain Score
Week 1
|
6.12 Units on a scale
Standard Error 0.18
|
5.42 Units on a scale
Standard Error 0.18
|
|
Daily Pain Score
Week 3
|
5.73 Units on a scale
Standard Error 0.19
|
5.14 Units on a scale
Standard Error 0.19
|
|
Daily Pain Score
Week 4
|
5.44 Units on a scale
Standard Error 0.20
|
4.92 Units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ETPopulation: ITT; LOCF
sWASO as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. Weekly values were calculated as the average of the participant's daily SSQ values.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Subjective Wake After Sleep Onset (sWASO)
Week 2
|
75.48 Minutes
Standard Error 3.91
|
59.43 Minutes
Standard Error 3.92
|
|
Subjective Wake After Sleep Onset (sWASO)
Week 3
|
74.97 Minutes
Standard Error 4.75
|
61.73 Minutes
Standard Error 4.76
|
|
Subjective Wake After Sleep Onset (sWASO)
Week 1
|
80.86 Minutes
Standard Error 3.71
|
62.59 Minutes
Standard Error 3.73
|
|
Subjective Wake After Sleep Onset (sWASO)
Week 4
|
69.65 Minutes
Standard Error 4.20
|
59.40 Minutes
Standard Error 4.21
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ETPopulation: ITT; LOCF
sTST as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Weekly values were calculated as the average of the participants daily SSQ values.
Outcome measures
| Measure |
Placebo
n=109 Participants
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=108 Participants
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Subjective Total Sleep Time (sTST)
Week 1
|
336.8 Minutes
Standard Error 5.40
|
361.7 Minutes
Standard Error 5.41
|
|
Subjective Total Sleep Time (sTST)
Week 2
|
341.9 Minutes
Standard Error 5.76
|
371.3 Minutes
Standard Error 5.77
|
|
Subjective Total Sleep Time (sTST)
Week 3
|
344.1 Minutes
Standard Error 5.73
|
370.9 Minutes
Standard Error 5.74
|
|
Subjective Total Sleep Time (sTST)
Week 4
|
352.5 Minutes
Standard Error 5.60
|
377.9 Minutes
Standard Error 5.61
|
Adverse Events
Placebo
Pregabalin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=111 participants at risk
Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
Pregabalin
n=112 participants at risk
Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
2.7%
3/111
The same event may appear as both an adverse events (AE) and a serious adverse events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.1%
8/112
The same event may appear as both an adverse events (AE) and a serious adverse events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
dizziness
|
9.9%
11/111
The same event may appear as both an adverse events (AE) and a serious adverse events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
30.4%
34/112
The same event may appear as both an adverse events (AE) and a serious adverse events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
headache
|
8.1%
9/111
The same event may appear as both an adverse events (AE) and a serious adverse events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.9%
10/112
The same event may appear as both an adverse events (AE) and a serious adverse events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
somnolence
|
4.5%
5/111
The same event may appear as both an adverse events (AE) and a serious adverse events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.5%
23/112
The same event may appear as both an adverse events (AE) and a serious adverse events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
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