Trial Outcomes & Findings for Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients (NCT NCT00676403)
NCT ID: NCT00676403
Last Updated: 2021-02-10
Results Overview
IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
137 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2021-02-10
Participant Flow
Subjects meeting entry criteria with a confirmed diagnosis of Restless Leg Syndrome completed a washout of medications if needed prior to starting a 7-day single-blind placebo run-in to identify and exclude placebo responders and to adapt subjects to take study drug 1-3 hours prior to bedtime. Of 218 subjects screened, 137 subjects entered.
Participant milestones
| Measure |
Placebo
Single daily oral dose.
|
Pregabalin 50 mg
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
23
|
22
|
24
|
23
|
|
Overall Study
COMPLETED
|
21
|
20
|
22
|
17
|
23
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
5
|
1
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Single daily oral dose.
|
Pregabalin 50 mg
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
5
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Reason Unspecified
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
Baseline characteristics by cohort
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
18 - 44 years
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
2 participants
n=4 Participants
|
9 participants
n=21 Participants
|
3 participants
n=10 Participants
|
30 participants
n=115 Participants
|
|
Age, Customized
45 - 64 years
|
19 participants
n=5 Participants
|
15 participants
n=7 Participants
|
16 participants
n=5 Participants
|
20 participants
n=4 Participants
|
15 participants
n=21 Participants
|
19 participants
n=10 Participants
|
104 participants
n=115 Participants
|
|
Age, Customized
>=65 years
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
3 participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
90 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: ITT. Baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. Recall period = week prior to assessment.
IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=21 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=20 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=22 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=18 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=23 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=20 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6
|
-7.73 scores on scale
Standard Error 1.720
|
-11.83 scores on scale
Standard Error 1.771
|
-11.76 scores on scale
Standard Error 1.694
|
-16.02 scores on scale
Standard Error 1.865
|
-12.89 scores on scale
Standard Error 1.713
|
-16.26 scores on scale
Standard Error 1.771
|
SECONDARY outcome
Timeframe: Week 6Population: ITT; N=number of subjects in a treatment group; n=number of subjects with a clinical Global Impressions Improvement (CGI-I) rating.
Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)
Week 6: Responders (n=21, 20, 22, 18, 23, 20)
|
13 participants
|
12 participants
|
15 participants
|
11 participants
|
17 participants
|
18 participants
|
|
Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I)
Week 6: Non-Responders
|
8 participants
|
8 participants
|
7 participants
|
7 participants
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)Population: ITT; N=number of subjects in a treatment group. LOCF: Last Observation Carried Forward.
CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
LOCF: Among the Most Extremely Ill
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Baseline: Normal, Not at All Ill
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Baseline: Mildly Ill
|
1 participants
|
1 participants
|
2 participants
|
4 participants
|
2 participants
|
2 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Baseline: Moderately Ill
|
6 participants
|
9 participants
|
8 participants
|
5 participants
|
11 participants
|
6 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Baseline: Markedly Ill
|
7 participants
|
8 participants
|
7 participants
|
5 participants
|
3 participants
|
5 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Baseline: Severely Ill
|
8 participants
|
3 participants
|
6 participants
|
7 participants
|
8 participants
|
10 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 1: Borderline, Mentally Ill
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 1: Mildly Ill
|
4 participants
|
6 participants
|
5 participants
|
8 participants
|
5 participants
|
7 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 1: Moderately Ill
|
10 participants
|
8 participants
|
5 participants
|
7 participants
|
6 participants
|
8 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 1: Markedly Ill
|
4 participants
|
3 participants
|
5 participants
|
1 participants
|
3 participants
|
2 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 2: Borderline, Mentally Ill
|
3 participants
|
4 participants
|
2 participants
|
3 participants
|
6 participants
|
2 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 2: Mildly Ill
|
10 participants
|
5 participants
|
9 participants
|
7 participants
|
4 participants
|
8 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 2: Moderately Ill
|
3 participants
|
5 participants
|
5 participants
|
6 participants
|
5 participants
|
3 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 2: Markedly Ill
|
3 participants
|
3 participants
|
4 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 2: Severely Ill
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 2: Among the Most Extremely Ill
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 4: Normal, Not at All Ill
|
1 participants
|
2 participants
|
2 participants
|
5 participants
|
4 participants
|
8 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 4: Borderline, Mentally Ill
|
4 participants
|
2 participants
|
2 participants
|
2 participants
|
6 participants
|
5 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 4: Mildly Ill
|
8 participants
|
7 participants
|
11 participants
|
5 participants
|
4 participants
|
4 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 4: Markedly Ill
|
3 participants
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 4: Among the Most Extremely Ill
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 6: Normal, Not at All Ill
|
1 participants
|
3 participants
|
4 participants
|
4 participants
|
6 participants
|
7 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 6: Borderline, Mentally Ill
|
3 participants
|
3 participants
|
4 participants
|
4 participants
|
4 participants
|
5 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 6: Mildly Ill
|
11 participants
|
6 participants
|
7 participants
|
7 participants
|
7 participants
|
6 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 6: Moderately Ill
|
2 participants
|
5 participants
|
5 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 6: Markedly Ill
|
2 participants
|
2 participants
|
2 participants
|
0 participants
|
4 participants
|
1 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 6: Severely Ill
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 6: Among the Most Extremely Ill
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
LOCF: Normal
|
1 participants
|
3 participants
|
4 participants
|
4 participants
|
6 participants
|
7 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
LOCF: Borderline, Mentally Ill
|
3 participants
|
3 participants
|
4 participants
|
4 participants
|
4 participants
|
6 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
LOCF: Mildly Ill
|
12 participants
|
6 participants
|
7 participants
|
9 participants
|
7 participants
|
7 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
LOCF: Moderately Ill
|
2 participants
|
6 participants
|
5 participants
|
5 participants
|
1 participants
|
1 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
LOCF: Markedly Ill
|
2 participants
|
2 participants
|
2 participants
|
0 participants
|
4 participants
|
1 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
LOCF: Severely Ill
|
2 participants
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Baseline: Borderline, Mentally Ill
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Baseline: Among the Most Extremely Ill
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 1: Normal, Not at All Ill
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
3 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 1: Severely Ill
|
4 participants
|
2 participants
|
3 participants
|
2 participants
|
5 participants
|
1 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 1: Among the Most Extremely Ill
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 2: Normal, Not at All Ill
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
7 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 4: Moderately Ill
|
4 participants
|
6 participants
|
6 participants
|
5 participants
|
5 participants
|
2 participants
|
|
Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S)
Week 4: Severely Ill
|
2 participants
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep \[in minutes\]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline
Week 1
|
-9.8 minutes
Standard Error 5.60
|
-16.3 minutes
Standard Error 5.76
|
-13.2 minutes
Standard Error 5.60
|
-10.4 minutes
Standard Error 5.76
|
-9.1 minutes
Standard Error 5.65
|
-20.2 minutes
Standard Error 5.62
|
|
Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline
Week 2
|
-8.9 minutes
Standard Error 5.60
|
-20.7 minutes
Standard Error 5.84
|
-17.2 minutes
Standard Error 5.65
|
-16.3 minutes
Standard Error 6.00
|
-13.0 minutes
Standard Error 5.71
|
-34.3 minutes
Standard Error 5.69
|
|
Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline
Week 3
|
-14.6 minutes
Standard Error 5.71
|
-18.9 minutes
Standard Error 5.90
|
-13.1 minutes
Standard Error 5.60
|
-17.8 minutes
Standard Error 6.00
|
-17.8 minutes
Standard Error 5.71
|
-33.7 minutes
Standard Error 5.88
|
|
Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline
Week 4
|
-13.6 minutes
Standard Error 5.66
|
-20.4 minutes
Standard Error 5.90
|
-20.4 minutes
Standard Error 5.60
|
-18.2 minutes
Standard Error 6.00
|
-18.2 minutes
Standard Error 5.71
|
-37.1 minutes
Standard Error 5.82
|
|
Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline
Week 5
|
-15.9 minutes
Standard Error 5.71
|
-26.8 minutes
Standard Error 5.90
|
-17.6 minutes
Standard Error 5.60
|
-24.0 minutes
Standard Error 6.07
|
-13.4 minutes
Standard Error 5.71
|
-36.1 minutes
Standard Error 5.82
|
|
Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline
Week 6
|
-12.4 minutes
Standard Error 5.71
|
-25.4 minutes
Standard Error 5.90
|
-19.5 minutes
Standard Error 5.65
|
-25.1 minutes
Standard Error 6.14
|
-10.1 minutes
Standard Error 5.71
|
-34.9 minutes
Standard Error 5.82
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6Population: ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline
Week 4
|
0.27 hours
Standard Error 0.180
|
0.81 hours
Standard Error 0.188
|
0.46 hours
Standard Error 0.177
|
0.93 hours
Standard Error 0.192
|
0.65 hours
Standard Error 0.180
|
1.03 hours
Standard Error 0.187
|
|
Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline
Week 5
|
0.37 hours
Standard Error 0.182
|
1.03 hours
Standard Error 0.188
|
0.43 hours
Standard Error 0.177
|
0.97 hours
Standard Error 0.195
|
0.61 hours
Standard Error 0.180
|
1.43 hours
Standard Error 0.187
|
|
Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline
Week 1
|
0.23 hours
Standard Error 0.177
|
0.57 hours
Standard Error 0.183
|
0.29 hours
Standard Error 0.177
|
0.55 hours
Standard Error 0.182
|
0.45 hours
Standard Error 0.177
|
0.72 hours
Standard Error 0.178
|
|
Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline
Week 3
|
0.36 hours
Standard Error 0.182
|
0.61 hours
Standard Error 0.188
|
0.53 hours
Standard Error 0.177
|
0.89 hours
Standard Error 0.192
|
0.72 hours
Standard Error 0.180
|
1.32 hours
Standard Error 0.189
|
|
Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline
Week 6
|
0.19 hours
Standard Error 0.182
|
0.84 hours
Standard Error 0.188
|
0.42 hours
Standard Error 0.179
|
0.95 hours
Standard Error 0.198
|
0.44 hours
Standard Error 0.180
|
1.11 hours
Standard Error 0.187
|
|
Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline
Week 2
|
0.36 hours
Standard Error 0.177
|
0.65 hours
Standard Error 0.186
|
0.52 hours
Standard Error 0.179
|
0.81 hours
Standard Error 0.192
|
0.76 hours
Standard Error 0.180
|
1.07 hours
Standard Error 0.181
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6Population: ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline in at least one post-baseline visit.
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline
Week 1
|
-0.5 awakenings
Standard Error 0.21
|
-0.9 awakenings
Standard Error 0.21
|
-1.0 awakenings
Standard Error 0.21
|
-1.2 awakenings
Standard Error 0.21
|
-0.7 awakenings
Standard Error 0.21
|
-0.8 awakenings
Standard Error 0.21
|
|
Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline
Week 2
|
-0.7 awakenings
Standard Error 0.21
|
-1.0 awakenings
Standard Error 0.22
|
-1.3 awakenings
Standard Error 0.21
|
-1.3 awakenings
Standard Error 0.23
|
-1.3 awakenings
Standard Error 0.21
|
-1.1 awakenings
Standard Error 0.21
|
|
Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline
Week 3
|
-0.7 awakenings
Standard Error 0.21
|
-1.0 awakenings
Standard Error 0.22
|
-1.0 awakenings
Standard Error 0.21
|
-1.3 awakenings
Standard Error 0.23
|
-1.2 awakenings
Standard Error 0.21
|
-1.4 awakenings
Standard Error 0.22
|
|
Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline
Week 4
|
-0.9 awakenings
Standard Error 0.21
|
-1.1 awakenings
Standard Error 0.22
|
-1.2 awakenings
Standard Error 0.21
|
-1.5 awakenings
Standard Error 0.23
|
-1.1 awakenings
Standard Error 0.21
|
-1.2 awakenings
Standard Error 0.22
|
|
Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline
Week 5
|
-0.8 awakenings
Standard Error 0.21
|
-1.3 awakenings
Standard Error 0.22
|
-1.0 awakenings
Standard Error 0.21
|
-1.6 awakenings
Standard Error 0.23
|
-1.2 awakenings
Standard Error 0.21
|
-1.5 awakenings
Standard Error 0.22
|
|
Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline
Week 6
|
-1.0 awakenings
Standard Error 0.21
|
-1.0 awakenings
Standard Error 0.22
|
-1.1 awakenings
Standard Error 0.21
|
-1.5 awakenings
Standard Error 0.23
|
-1.0 awakenings
Standard Error 0.21
|
-1.2 awakenings
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6Population: ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit.
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline
Week 1
|
-23.8 minutes
Standard Error 7.44
|
-37.9 minutes
Standard Error 7.66
|
-28.5 minutes
Standard Error 7.47
|
-29.0 minutes
Standard Error 7.81
|
-32.2 minutes
Standard Error 7.58
|
-32.6 minutes
Standard Error 7.46
|
|
Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline
Week 3
|
-34.3 minutes
Standard Error 7.62
|
-51.4 minutes
Standard Error 8.01
|
-32.0 minutes
Standard Error 7.47
|
-45.9 minutes
Standard Error 8.23
|
-42.3 minutes
Standard Error 7.59
|
-42.9 minutes
Standard Error 7.89
|
|
Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline
Week 4
|
-30.4 minutes
Standard Error 7.53
|
-50.7 minutes
Standard Error 8.01
|
-36.5 minutes
Standard Error 7.47
|
-46.0 minutes
Standard Error 8.23
|
-43.6 minutes
Standard Error 7.68
|
-46.8 minutes
Standard Error 7.79
|
|
Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline
Week 5
|
-28.7 minutes
Standard Error 7.62
|
-55.4 minutes
Standard Error 8.01
|
-30.7 minutes
Standard Error 7.47
|
-59.6 minutes
Standard Error 8.36
|
-42.5 minutes
Standard Error 7.59
|
-55.1 minutes
Standard Error 7.79
|
|
Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline
Week 6
|
-34.2 minutes
Standard Error 7.62
|
-57.0 minutes
Standard Error 7.90
|
-34.2 minutes
Standard Error 7.55
|
-54.0 minutes
Standard Error 8.49
|
-41.1 minutes
Standard Error 7.68
|
-55.5 minutes
Standard Error 7.89
|
|
Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline
Week 2
|
-29.5 minutes
Standard Error 7.44
|
-47.0 minutes
Standard Error 7.79
|
-36.5 minutes
Standard Error 7.55
|
-41.9 minutes
Standard Error 8.23
|
-39.8 minutes
Standard Error 7.68
|
-46.3 minutes
Standard Error 7.57
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline
Week 1
|
5.0 scores on scale
Standard Error 4.10
|
18.8 scores on scale
Standard Error 4.21
|
15.2 scores on scale
Standard Error 4.10
|
15.9 scores on scale
Standard Error 4.23
|
11.5 scores on scale
Standard Error 4.16
|
17.2 scores on scale
Standard Error 4.11
|
|
Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline
Week 2
|
11.3 scores on scale
Standard Error 4.10
|
23.3 scores on scale
Standard Error 4.27
|
18.7 scores on scale
Standard Error 4.13
|
24.2 scores on scale
Standard Error 4.40
|
23.4 scores on scale
Standard Error 4.20
|
24.0 scores on scale
Standard Error 4.16
|
|
Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline
Week 4
|
13.2 scores on scale
Standard Error 4.14
|
23.8 scores on scale
Standard Error 4.31
|
22.0 scores on scale
Standard Error 4.10
|
28.2 scores on scale
Standard Error 4.40
|
24.2 scores on scale
Standard Error 4.20
|
23.8 scores on scale
Standard Error 4.25
|
|
Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline
Week 5
|
14.7 scores on scale
Standard Error 4.17
|
28.7 scores on scale
Standard Error 4.31
|
19.9 scores on scale
Standard Error 4.10
|
30.9 scores on scale
Standard Error 4.45
|
26.0 scores on scale
Standard Error 4.20
|
31.1 scores on scale
Standard Error 4.25
|
|
Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline
Week 6
|
13.9 scores on scale
Standard Error 4.17
|
27.6 scores on scale
Standard Error 4.31
|
23.5 scores on scale
Standard Error 4.14
|
30.5 scores on scale
Standard Error 4.50
|
23.1 scores on scale
Standard Error 4.20
|
28.8 scores on scale
Standard Error 4.25
|
|
Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline
Week 3
|
13.8 scores on scale
Standard Error 4.17
|
23.0 scores on scale
Standard Error 4.31
|
18.6 scores on scale
Standard Error 4.10
|
26.8 scores on scale
Standard Error 4.40
|
23.6 scores on scale
Standard Error 4.20
|
25.4 scores on scale
Standard Error 4.29
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6Population: ITT, Baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline
Week 1
|
-9.0 scores on scale
Standard Error 4.76
|
-18.2 scores on scale
Standard Error 5.05
|
-21.1 scores on scale
Standard Error 4.87
|
-23.0 scores on scale
Standard Error 5.26
|
-17.7 scores on scale
Standard Error 4.93
|
-26.3 scores on scale
Standard Error 4.89
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline
Week 2
|
-15.7 scores on scale
Standard Error 4.76
|
-25.1 scores on scale
Standard Error 5.14
|
-23.0 scores on scale
Standard Error 4.81
|
-26.1 scores on scale
Standard Error 5.30
|
-35.3 scores on scale
Standard Error 4.95
|
-32.1 scores on scale
Standard Error 5.02
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline
Week 4
|
-22.0 scores on scale
Standard Error 4.81
|
-18.5 scores on scale
Standard Error 5.07
|
-28.3 scores on scale
Standard Error 4.76
|
-32.4 scores on scale
Standard Error 5.30
|
-34.2 scores on scale
Standard Error 4.95
|
-37.4 scores on scale
Standard Error 5.02
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline
Week 6
|
-19.3 scores on scale
Standard Error 4.87
|
-29.2 scores on scale
Standard Error 5.14
|
-25.3 scores on scale
Standard Error 4.81
|
-33.4 scores on scale
Standard Error 5.38
|
-31.4 scores on scale
Standard Error 4.95
|
-40.2 scores on scale
Standard Error 5.02
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline
Week 4
|
-3.2 scores on scale
Standard Error 5.44
|
4.4 scores on scale
Standard Error 5.75
|
-4.0 scores on scale
Standard Error 5.42
|
-7.5 scores on scale
Standard Error 6.16
|
2.8 scores on scale
Standard Error 5.48
|
-3.5 scores on scale
Standard Error 5.67
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline
Week 1
|
-2.4 scores on scale
Standard Error 5.39
|
5.2 scores on scale
Standard Error 5.72
|
-8.6 scores on scale
Standard Error 5.53
|
0.7 scores on scale
Standard Error 6.04
|
-2.9 scores on scale
Standard Error 5.46
|
-9.2 scores on scale
Standard Error 5.54
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline
Week 2
|
-1.5 scores on scale
Standard Error 5.39
|
-0.8 scores on scale
Standard Error 5.81
|
-11.4 scores on scale
Standard Error 5.47
|
-8.7 scores on scale
Standard Error 6.16
|
-3.3 scores on scale
Standard Error 5.48
|
-12.2 scores on scale
Standard Error 5.66
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline
Week 6
|
-2.1 scores on scale
Standard Error 5.50
|
2.5 scores on scale
Standard Error 5.81
|
-6.6 scores on scale
Standard Error 5.47
|
-2.0 scores on scale
Standard Error 6.24
|
1.0 scores on scale
Standard Error 5.48
|
-7.5 scores on scale
Standard Error 5.67
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline
Week 2
|
-9.1 scores on scale
Standard Error 3.49
|
-4.3 scores on scale
Standard Error 3.81
|
-8.8 scores on scale
Standard Error 3.54
|
-12.1 scores on scale
Standard Error 3.93
|
-8.2 scores on scale
Standard Error 3.53
|
-1.1 scores on scale
Standard Error 3.72
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline
Week 4
|
-9.9 scores on scale
Standard Error 3.56
|
-2.5 scores on scale
Standard Error 3.73
|
-8.9 scores on scale
Standard Error 3.47
|
-9.9 scores on scale
Standard Error 3.93
|
-9.1 scores on scale
Standard Error 3.53
|
-9.2 scores on scale
Standard Error 3.73
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline
Week 6
|
-7.4 scores on scale
Standard Error 3.63
|
-0.9 scores on scale
Standard Error 3.81
|
-4.9 scores on scale
Standard Error 3.54
|
-11.5 scores on scale
Standard Error 4.03
|
-3.0 scores on scale
Standard Error 3.53
|
-8.2 scores on scale
Standard Error 3.73
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline
Week 1
|
-7.3 scores on scale
Standard Error 3.49
|
-1.7 scores on scale
Standard Error 3.72
|
-5.3 scores on scale
Standard Error 3.62
|
-9.2 scores on scale
Standard Error 3.92
|
-8.6 scores on scale
Standard Error 3.51
|
1.4 scores on scale
Standard Error 3.58
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline
Week 1
|
5.2 scores on scale
Standard Error 5.38
|
16.1 scores on scale
Standard Error 5.76
|
5.3 scores on scale
Standard Error 5.53
|
13.7 scores on scale
Standard Error 6.01
|
9.8 scores on scale
Standard Error 5.50
|
16.1 scores on scale
Standard Error 5.58
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline
Week 2
|
15.6 scores on scale
Standard Error 5.38
|
31.0 scores on scale
Standard Error 5.87
|
19.6 scores on scale
Standard Error 5.45
|
21.9 scores on scale
Standard Error 6.06
|
14.0 scores on scale
Standard Error 5.53
|
29.5 scores on scale
Standard Error 5.76
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline
Week 4
|
15.6 scores on scale
Standard Error 5.45
|
23.9 scores on scale
Standard Error 5.78
|
20.8 scores on scale
Standard Error 5.38
|
24.7 scores on scale
Standard Error 6.06
|
26.6 scores on scale
Standard Error 5.53
|
34.6 scores on scale
Standard Error 5.78
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline
Week 6
|
16.8 scores on scale
Standard Error 5.54
|
34.6 scores on scale
Standard Error 5.87
|
27.0 scores on scale
Standard Error 5.45
|
26.8 scores on scale
Standard Error 6.17
|
19.2 scores on scale
Standard Error 5.53
|
31.1 scores on scale
Standard Error 5.78
|
SECONDARY outcome
Timeframe: Baseline,, Week 1, Week 2, Week 4, Week 6Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline
Week 2
|
-13.9 scores on scale
Standard Error 4.02
|
-18.2 scores on scale
Standard Error 4.36
|
-11.1 scores on scale
Standard Error 4.07
|
-18.8 scores on scale
Standard Error 4.49
|
-11.3 scores on scale
Standard Error 4.09
|
-12.6 scores on scale
Standard Error 4.25
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline
Week 4
|
-14.0 scores on scale
Standard Error 4.07
|
-20.4 scores on scale
Standard Error 4.30
|
-11.8 scores on scale
Standard Error 4.02
|
-16.2 scores on scale
Standard Error 4.49
|
-16.9 scores on scale
Standard Error 4.09
|
-12.6 scores on scale
Standard Error 4.26
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline
Week 1
|
-7.4 scores on scale
Standard Error 4.02
|
-13.8 scores on scale
Standard Error 4.29
|
-9.8 scores on scale
Standard Error 4.12
|
-14.3 scores on scale
Standard Error 4.46
|
-11.2 scores on scale
Standard Error 4.07
|
-10.7 scores on scale
Standard Error 4.14
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline
Week 6
|
-11.7 scores on scale
Standard Error 4.12
|
-26.3 scores on scale
Standard Error 4.36
|
-14.8 scores on scale
Standard Error 4.07
|
-21.7 scores on scale
Standard Error 4.56
|
-13.4 scores on scale
Standard Error 4.09
|
-13.9 scores on scale
Standard Error 4.26
|
SECONDARY outcome
Timeframe: Baseline,, Week 1, Week 2, Week 4, Week 6Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline
Week 1
|
0.4 scores on scale
Standard Error 0.21
|
0.7 scores on scale
Standard Error 0.22
|
0.5 scores on scale
Standard Error 0.22
|
0.9 scores on scale
Standard Error 0.23
|
0.4 scores on scale
Standard Error 0.21
|
0.7 scores on scale
Standard Error 0.22
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline
Week 2
|
0.5 scores on scale
Standard Error 0.21
|
0.8 scores on scale
Standard Error 0.23
|
0.6 scores on scale
Standard Error 0.21
|
1.2 scores on scale
Standard Error 0.23
|
0.7 scores on scale
Standard Error 0.21
|
1.1 scores on scale
Standard Error 0.22
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline
Week 4
|
0.6 scores on scale
Standard Error 0.21
|
1.0 scores on scale
Standard Error 0.22
|
0.7 scores on scale
Standard Error 0.21
|
1.4 scores on scale
Standard Error 0.23
|
1.1 scores on scale
Standard Error 0.21
|
1.1 scores on scale
Standard Error 0.22
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline
Week 6
|
0.6 scores on scale
Standard Error 0.22
|
0.9 scores on scale
Standard Error 0.23
|
0.7 scores on scale
Standard Error 0.21
|
1.3 scores on scale
Standard Error 0.24
|
0.7 scores on scale
Standard Error 0.21
|
1.2 scores on scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline
Week 1
|
-9.2 scores on scale
Standard Error 3.67
|
-12.5 scores on scale
Standard Error 3.91
|
-10.4 scores on scale
Standard Error 3.75
|
-14.9 scores on scale
Standard Error 4.06
|
-13.9 scores on scale
Standard Error 3.77
|
-16.2 scores on scale
Standard Error 3.77
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline
Week 2
|
-14.8 scores on scale
Standard Error 3.67
|
-22.0 scores on scale
Standard Error 3.97
|
-15.7 scores on scale
Standard Error 3.71
|
-20.3 scores on scale
Standard Error 4.09
|
-20.1 scores on scale
Standard Error 3.79
|
-24.1 scores on scale
Standard Error 3.87
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline
Week 6
|
-15.5 scores on scale
Standard Error 3.76
|
-25.0 scores on scale
Standard Error 3.97
|
-21.1 scores on scale
Standard Error 3.71
|
-26.1 scores on scale
Standard Error 4.15
|
-18.8 scores on scale
Standard Error 3.79
|
-27.6 scores on scale
Standard Error 3.88
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline
Week 4
|
-17.2 scores on scale
Standard Error 3.71
|
-17.9 scores on scale
Standard Error 3.92
|
-19.6 scores on scale
Standard Error 3.67
|
-23.3 scores on scale
Standard Error 4.09
|
-24.4 scores on scale
Standard Error 3.79
|
-28.9 scores on scale
Standard Error 3.88
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6Population: ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit.
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline
Week 4
|
-18.2 scores on scale
Standard Error 3.77
|
-19.3 scores on scale
Standard Error 3.98
|
-22.0 scores on scale
Standard Error 3.73
|
-25.2 scores on scale
Standard Error 4.15
|
-27.0 scores on scale
Standard Error 3.86
|
-29.1 scores on scale
Standard Error 3.93
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline
Week 1
|
-8.1 scores on scale
Standard Error 3.73
|
-15.9 scores on scale
Standard Error 3.96
|
-14.2 scores on scale
Standard Error 3.81
|
-17.8 scores on scale
Standard Error 4.12
|
-14.4 scores on scale
Standard Error 3.84
|
-18.8 scores on scale
Standard Error 3.83
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline
Week 2
|
-15.5 scores on scale
Standard Error 3.73
|
-23.5 scores on scale
Standard Error 4.03
|
-19.0 scores on scale
Standard Error 3.76
|
-22.5 scores on scale
Standard Error 4.15
|
-23.3 scores on scale
Standard Error 3.86
|
-24.6 scores on scale
Standard Error 3.93
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline
Week 6
|
-16.8 scores on scale
Standard Error 3.81
|
-27.5 scores on scale
Standard Error 4.03
|
-22.2 scores on scale
Standard Error 3.76
|
-28.3 scores on scale
Standard Error 4.21
|
-22.3 scores on scale
Standard Error 3.86
|
-29.4 scores on scale
Standard Error 3.93
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 4, Week 6Population: ITT
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week
Week 1
|
6 participants
|
10 participants
|
7 participants
|
9 participants
|
6 participants
|
11 participants
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week
Week 4
|
11 participants
|
12 participants
|
11 participants
|
10 participants
|
14 participants
|
11 participants
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week
Week 6
|
12 participants
|
11 participants
|
11 participants
|
10 participants
|
9 participants
|
13 participants
|
|
Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week
Week 2
|
8 participants
|
6 participants
|
11 participants
|
9 participants
|
12 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, and had baseline and post-baseline values.
RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6
|
15.0 scores on scales
Standard Error 3.71
|
19.6 scores on scales
Standard Error 3.87
|
22.4 scores on scales
Standard Error 3.55
|
20.8 scores on scales
Standard Error 3.94
|
15.9 scores on scales
Standard Error 3.63
|
20.5 scores on scales
Standard Error 3.74
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, had baseline and post-baseline values.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Social Functioning
|
7.8 scores on scale
Standard Error 3.98
|
8.3 scores on scale
Standard Error 4.20
|
4.8 scores on scale
Standard Error 3.88
|
4.4 scores on scale
Standard Error 4.47
|
9.5 scores on scale
Standard Error 4.00
|
15.6 scores on scale
Standard Error 4.10
|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Role-Emotional
|
-2.1 scores on scale
Standard Error 4.16
|
6.7 scores on scale
Standard Error 4.38
|
7.8 scores on scale
Standard Error 4.05
|
1.0 scores on scale
Standard Error 4.63
|
8.1 scores on scale
Standard Error 4.13
|
12.7 scores on scale
Standard Error 4.31
|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Physical Functioning
|
3.6 scores on scale
Standard Error 3.50
|
0.5 scores on scale
Standard Error 3.71
|
2.4 scores on scale
Standard Error 3.42
|
-0.4 scores on scale
Standard Error 3.93
|
2.9 scores on scale
Standard Error 3.52
|
3.6 scores on scale
Standard Error 3.62
|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Role-Physical
|
1.1 scores on scale
Standard Error 4.24
|
7.0 scores on scale
Standard Error 4.49
|
7.5 scores on scale
Standard Error 4.14
|
7.7 scores on scale
Standard Error 4.77
|
0.9 scores on scale
Standard Error 4.24
|
9.6 scores on scale
Standard Error 4.40
|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Bodily Pain
|
6.9 scores on scale
Standard Error 4.16
|
15.8 scores on scale
Standard Error 4.41
|
12.9 scores on scale
Standard Error 4.07
|
16.9 scores on scale
Standard Error 4.87
|
13.3 scores on scale
Standard Error 4.17
|
18.1 scores on scale
Standard Error 4.31
|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
General Health
|
6.5 scores on scale
Standard Error 2.81
|
5.2 scores on scale
Standard Error 3.05
|
4.0 scores on scale
Standard Error 2.75
|
7.5 scores on scale
Standard Error 3.15
|
3.6 scores on scale
Standard Error 2.82
|
5.9 scores on scale
Standard Error 2.90
|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Vitality
|
7.4 scores on scale
Standard Error 3.98
|
11.1 scores on scale
Standard Error 4.18
|
9.9 scores on scale
Standard Error 3.86
|
18.5 scores on scale
Standard Error 4.46
|
11.7 scores on scale
Standard Error 3.95
|
13.9 scores on scale
Standard Error 4.08
|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Mental Health
|
2.9 scores on scale
Standard Error 3.49
|
1.0 scores on scale
Standard Error 3.68
|
3.6 scores on scale
Standard Error 3.43
|
7.6 scores on scale
Standard Error 3.90
|
3.7 scores on scale
Standard Error 3.47
|
10.7 scores on scale
Standard Error 3.59
|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Summary Physical Score
|
4.5 scores on scale
Standard Error 2.83
|
7.4 scores on scale
Standard Error 3.02
|
6.7 scores on scale
Standard Error 2.77
|
8.2 scores on scale
Standard Error 3.29
|
5.6 scores on scale
Standard Error 2.85
|
9.7 scores on scale
Standard Error 2.94
|
|
Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6
Summary Emotional Score
|
3.7 scores on scale
Standard Error 3.33
|
6.9 scores on scale
Standard Error 3.51
|
6.7 scores on scale
Standard Error 3.24
|
8.2 scores on scale
Standard Error 3.72
|
8.5 scores on scale
Standard Error 3.32
|
13.5 scores on scale
Standard Error 3.43
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: ITT; N = number of subjects in a treatment group.
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from "much worse now" to much better now." Recall period: month prior to the assessment.
Outcome measures
| Measure |
Placebo
n=23 Participants
Single daily oral dose.
|
Pregabalin 50 mg
n=22 Participants
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 Participants
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 Participants
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 Participants
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 Participants
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Baseline: Somewhat Worse than 1 Year Ago
|
4 participants
|
6 participants
|
3 participants
|
4 participants
|
1 participants
|
3 participants
|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Baseline: About the Same as 1 Year Ago
|
15 participants
|
9 participants
|
15 participants
|
14 participants
|
14 participants
|
12 participants
|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Baseline: Somewhat Better than 1 Year Ago
|
2 participants
|
1 participants
|
3 participants
|
0 participants
|
5 participants
|
2 participants
|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Baseline: Much Better than 1 Year Ago
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Week 6: Much Worse than 1 Year Ago
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Week 6: About the Same as 1 Year Ago
|
11 participants
|
12 participants
|
10 participants
|
11 participants
|
12 participants
|
10 participants
|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Week 6: Much Better than 1 Year Ago
|
3 participants
|
2 participants
|
6 participants
|
1 participants
|
2 participants
|
4 participants
|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Baseline: Much Worse than 1 Year Ago
|
0 participants
|
3 participants
|
1 participants
|
2 participants
|
3 participants
|
2 participants
|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Week 6: Somewhat Worse than 1 Year Ago
|
2 participants
|
3 participants
|
2 participants
|
4 participants
|
3 participants
|
1 participants
|
|
Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores
Week 6: Somewhat Better than 1 Year Ago
|
4 participants
|
2 participants
|
4 participants
|
1 participants
|
4 participants
|
5 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Pregabalin 50 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Pregabalin 100 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Pregabalin 150 mg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Pregabalin 300 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Pregabalin 450 mg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=23 participants at risk
Single daily oral dose.
|
Pregabalin 50 mg
n=22 participants at risk
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 participants at risk
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 participants at risk
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 participants at risk
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 participants at risk
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
Other adverse events
| Measure |
Placebo
n=23 participants at risk
Single daily oral dose.
|
Pregabalin 50 mg
n=22 participants at risk
Single daily 50 mg oral dose.
|
Pregabalin 100 mg
n=23 participants at risk
Single daily 100 mg oral dose. Dose was escalated from 50 mg/day after Day 3.
|
Pregabalin 150 mg
n=22 participants at risk
Single daily 150 mg oral dose. Dose was escalated from 75 mg/day after Day 3.
|
Pregabalin 300 mg
n=24 participants at risk
Single daily 300 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), and 150 mg/day (Days 4-7).
|
Pregabalin 450 mg
n=23 participants at risk
Single daily 450 mg oral dose. Dose was escalated from 75 mg/day (Days 1-3), 150 mg/day (Days 4-7), and 300 mg/day (Days 8-11).
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Eye disorders
Diplopia
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
4.5%
1/22
|
8.3%
2/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
12.5%
3/24
|
8.7%
2/23
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23
|
4.5%
1/22
|
0.00%
0/23
|
9.1%
2/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
General disorders
Chest discomfort
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
Chills
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
General disorders
Fatigue
|
0.00%
0/23
|
0.00%
0/22
|
17.4%
4/23
|
9.1%
2/22
|
4.2%
1/24
|
8.7%
2/23
|
|
General disorders
Feeling abnormal
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
8.3%
2/24
|
4.3%
1/23
|
|
General disorders
Feeling drunk
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
8.7%
2/23
|
|
General disorders
Feeling jittery
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
Feeling of relaxation
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
General disorders
Gait disturbance
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
4.2%
1/24
|
4.3%
1/23
|
|
General disorders
Hangover
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
General disorders
Mucosal dryness
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
Oedema peripheral
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
General disorders
Thirst
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Infections and infestations
Cystitis
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Infections and infestations
Fungal infection
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Infections and infestations
Influenza
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Infections and infestations
Kidney infection
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Infections and infestations
Lower respiratory tract infection
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
4.2%
1/24
|
4.3%
1/23
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Infections and infestations
Sinusitis
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
4.5%
1/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
1/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
8.3%
2/24
|
0.00%
0/23
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Investigations
Blood pressure increased
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Investigations
Blood thyroid stimulating hormone increased
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Investigations
Creatinine renal clearance increased
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Investigations
Mean cell volume increased
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Investigations
Transaminases increased
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Investigations
Weight increased
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Investigations
White blood cell count decreased
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
4.3%
1/23
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
4.5%
1/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Amnesia
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Disturbance in attention
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23
|
0.00%
0/22
|
8.7%
2/23
|
22.7%
5/22
|
8.3%
2/24
|
30.4%
7/23
|
|
Nervous system disorders
Dyslalia
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Nervous system disorders
Headache
|
13.0%
3/23
|
22.7%
5/22
|
8.7%
2/23
|
9.1%
2/22
|
16.7%
4/24
|
8.7%
2/23
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Lethargy
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Nervous system disorders
Paraesthesia
|
4.3%
1/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Nervous system disorders
Post-traumatic headache
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Sciatica
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Nervous system disorders
Sedation
|
8.7%
2/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Nervous system disorders
Somnolence
|
4.3%
1/23
|
0.00%
0/22
|
4.3%
1/23
|
27.3%
6/22
|
25.0%
6/24
|
21.7%
5/23
|
|
Nervous system disorders
Tunnel vision
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Psychiatric disorders
Abnormal dreams
|
13.0%
3/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Psychiatric disorders
Depression
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Psychiatric disorders
Elevated mood
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
4.3%
1/23
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Psychiatric disorders
Restlessness
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Psychiatric disorders
Stress
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
4.3%
1/23
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
8.3%
2/24
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
4.2%
1/24
|
4.3%
1/23
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23
|
0.00%
0/22
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
4.5%
1/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23
|
4.5%
1/22
|
4.3%
1/23
|
4.5%
1/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Surgical and medical procedures
Tooth extraction
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Vascular disorders
Hot flush
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
9.1%
2/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Vascular disorders
Hypotension
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
4.2%
1/24
|
0.00%
0/23
|
|
Eye disorders
Eyelid oedema
|
4.3%
1/23
|
0.00%
0/22
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/24
|
0.00%
0/23
|
|
Eye disorders
Vision blurred
|
0.00%
0/23
|
0.00%
0/22
|
0.00%
0/23
|
9.1%
2/22
|
4.2%
1/24
|
8.7%
2/23
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 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