Trial Outcomes & Findings for The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome (NCT NCT00357097)
NCT ID: NCT00357097
Last Updated: 2012-06-07
Results Overview
Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.
COMPLETED
PHASE3
240 participants
Baseline and Week 12
2012-06-07
Participant Flow
Participant milestones
| Measure |
Ropinirole
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
Subjects who took no investigational product.
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
67
|
|
Overall Study
COMPLETED
|
145
|
38
|
|
Overall Study
NOT COMPLETED
|
54
|
29
|
Reasons for withdrawal
| Measure |
Ropinirole
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
Subjects who took no investigational product.
|
|---|---|---|
|
Overall Study
Did not meet inclusion criteria
|
5
|
3
|
|
Overall Study
Adverse Event
|
34
|
6
|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
|
Overall Study
Non-compliance
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
8
|
|
Overall Study
Met Exclusion Criteria
|
3
|
1
|
|
Overall Study
Other
|
1
|
1
|
|
Overall Study
Increase of RLS Symptoms
|
0
|
1
|
Baseline Characteristics
The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome
Baseline characteristics by cohort
| Measure |
Ropinirole
n=198 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=67 Participants
Subjects who took no investigational product.
|
Total
n=265 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.2 Years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
59.5 Years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
58.5 Years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
189.0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
76.0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low scores for this population were 32/11.
Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.
Outcome measures
| Measure |
Ropinirole
n=171 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=60 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment
|
-10.1 Score on a Scale
Standard Deviation 7.3
|
-6.5 Score on a Scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores\>=18: Ropinirole 91 and Placebo 29. The high/Low scores for the mITT population were 32/11.
Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.
Outcome measures
| Measure |
Ropinirole
n=91 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=29 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of at Least Moderate Depression (MADRS Score: >=18)
|
-12.5 Score on a Scale
Standard Deviation 8.0
|
-8.8 Score on a Scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). The High/Low HAM-D scores for this population were 27/5.
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).
Outcome measures
| Measure |
Ropinirole
n=166 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=55 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Average Change of the HAM-D (Hamilton Depression Rating Scale, 17-item-Version) Total Score From Baseline to Final Visit After 12 Weeks of Treatment
|
-8.2 Score on a Scale
Standard Deviation 5.5
|
-5.5 Score on a Scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores\>=15: Ropinirole 93 and Placebo 33
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54(severely ill).
Outcome measures
| Measure |
Ropinirole
n=93 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=33 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Average Change of the HAM-D Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Moderate Depression (HAM-D Score >= 15) at Baseline
|
-9.6 Score on a Scale
Standard Deviation 5.9
|
-7.2 Score on a Scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). High/Low BDI scores for this population were 46/2.
Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.
Outcome measures
| Measure |
Ropinirole
n=169 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=60 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment
|
-8.6 Score on a Scale
Standard Deviation 7.0
|
-6.5 Score on a Scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with BDI scores\>=21: Ropinirole 75 and Placebo 28. High/Low BDI scores for this population were 46/2.
Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and total score 0-63.
Outcome measures
| Measure |
Ropinirole
n=75 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=28 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment in Participants With Signs of an at Least Mild-moderate Depression (BDI >= 21) at Baseline
|
-10.9 Score on a Scale
Standard Deviation 7.9
|
-9.9 Score on a Scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at week 12).
Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.
Outcome measures
| Measure |
Ropinirole
n=171 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=60 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12
|
11.7 Percentage of Participants
|
23.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with HAM-D scores\>=15.
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).
Outcome measures
| Measure |
Ropinirole
n=168 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=56 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12
|
10.7 Percentage of Participants
|
26.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5).
Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.
Outcome measures
| Measure |
Ropinirole
n=171 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=60 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Percentage of Participants ("Responder") With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline
|
74.9 Percentage of Participants
|
48.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population with MADRS scores\>=18: Ropinirole 91 and Placebo 29
Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.
Outcome measures
| Measure |
Ropinirole
n=91 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=29 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Percentage of Participants ("Responder") With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline in Subjects With Signs of at Least Moderate Depression at Baseline (MADRS Score >= 18)
|
80.2 Percentage of Participants
|
58.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 93 and Placebo 34
Montgomery-Asberg Depression Rating Scale (MADRS)is a 10 item questionaire preformed during a clinical interview asking broad to detailed questions about symptoms which allows a precise rating of severity of symptoms of the past week. Questions are scored 0-6. Total Score 0-60, the higher the score indicates the most severely depressed patients.
Outcome measures
| Measure |
Ropinirole
n=93 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=34 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Change in Average MADRS Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)
|
-11.6 Score on a Scale
Standard Deviation 7.7
|
-7.6 Score on a Scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 90 and Placebo 31.
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAMD score range from 0 (not ill) to 54 (severely ill).
Outcome measures
| Measure |
Ropinirole
n=90 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=31 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Change in Average HAM-D Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)
|
-9.2 Score on a Scale
Standard Deviation 5.6
|
-6.5 Score on a Scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5). Sub-population diagnosed by MINI interview with Major Depressive Episodes: Ropinirole 91 and Placebo 34. High/Low BDI scores for this population were 46/2.
Becks Depression Inventory (BDI) is a 21 item self inventory evaluating symptoms of depression, cognition, and physical symptoms of fatigue, weight loss, and lack of interest in sex. The Higher the score represents most severely depressed participants. Score range for each items is 0-3 and Total score 0-63.
Outcome measures
| Measure |
Ropinirole
n=91 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=34 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Change in Average BDI Score From Baseline to Final Visit (Week 12) in Participants With Major Depressive Episodes (Diagnosed by MINI Interview Modules A, B and C / DSM Criteria)
|
-10.4 Score on a Scale
Standard Deviation 6.8
|
-7.2 Score on a Scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Baseline, Week 1, Week 4, Week 12Population: Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points
Outcome measures
| Measure |
Ropinirole
n=171 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=60 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks
Change from Baseline after 1 Week
|
-7.7 Score on a Scale
Standard Deviation 8.0
|
-4.1 Score on a Scale
Standard Deviation 5.4
|
|
Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks
Change from Baseline after 4 Weeks
|
-14.0 Score on a Scale
Standard Deviation 9.2
|
-8.6 Score on a Scale
Standard Deviation 8.5
|
|
Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks
Change from Baseline after 12 Weeks
|
-14.6 Score on a Scale
Standard Deviation 9.2
|
-10.2 Score on a Scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Week 1, Week 4, Week 12Population: Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
International Restless Legs Scale for Severity (IRLS)is a series of 10 questions which rate severity from 0-4 points for various questions and total score ranks: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, and Mild=1-10 points, None=0 points
Outcome measures
| Measure |
Ropinirole
n=171 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=60 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks
1 Week
|
52.6 Percentage of Participants
|
28.3 Percentage of Participants
|
|
Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks
4 Weeks
|
80.7 Percentage of Participants
|
58.3 Percentage of Participants
|
|
Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks
12 Weeks
|
84.8 Percentage of Participants
|
61.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 1, Week 4, Week 12Population: Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score range: 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5- minimally worse, 6-much worse, to 7-very much worse.
Outcome measures
| Measure |
Ropinirole
n=171 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=60 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Percentage of Participants With "Much Improved" or "Very Much Improved" on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks
Week 1
|
35.1 Percentage of Participants
|
15.0 Percentage of Participants
|
|
Percentage of Participants With "Much Improved" or "Very Much Improved" on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks
Week 4
|
66.7 Percentage of Participants
|
40.0 Percentage of Participants
|
|
Percentage of Participants With "Much Improved" or "Very Much Improved" on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks
Week 12
|
64.3 Percentage of Participants
|
46.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and after Week 12Population: Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.
Outcome measures
| Measure |
Ropinirole
n=171 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=59 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Change From Average Baseline Score of Subscale of "Somnolence" in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks
|
-12.5 Score on a Scale
Standard Deviation 19.4
|
-10.2 Score on a Scale
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: Baseline and after Week 12Population: Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.
Outcome measures
| Measure |
Ropinirole
n=167 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=59 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Change From Average Baseline Scores of Subscale "Sleep Disturbance" of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks
|
-30.5 Score on a Scale
Standard Deviation 24.5
|
-15.8 Score on a Scale
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: Baseline and after Week 12Population: Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Medical Outcome Study Sleep Scale (MOS-SS)-is a 12 item questionaire assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. 10 question score from 1-6, 1 question scores 1-5 and 1 question asks average number of hours sleep each night.
Outcome measures
| Measure |
Ropinirole
n=170 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=59 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Change From Average Baseline Scores of Subscale "Sleep Adequacy" of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks
|
34.0 Score on a Scale
Standard Deviation 30.6
|
15.6 Score on a Scale
Standard Deviation 36.2
|
SECONDARY outcome
Timeframe: Baseline and after Week 12Population: Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Outcome measures
| Measure |
Ropinirole
n=170 Participants
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
n=59 Participants
Subjects who took no investigational product.
|
|---|---|---|
|
Change From Average Baseline Scores of Subscale "Sleep Quantity" (Hours) of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks
|
1.3 Score on a Scale
Standard Deviation 1.3
|
0.5 Score on a Scale
Standard Deviation 1.4
|
Adverse Events
Ropinirole
Placebo
Serious adverse events
| Measure |
Ropinirole
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
Subjects who took no investigational product.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Back Pain
|
0.51%
1/197
|
0.00%
0/67
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.51%
1/197
|
0.00%
0/67
|
|
Gastrointestinal disorders
Nausea
|
0.51%
1/197
|
0.00%
0/67
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
1/197
|
0.00%
0/67
|
|
Infections and infestations
Bronchitis
|
0.51%
1/197 • Number of events 1
|
0.00%
0/67
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Missed
|
0.51%
1/197 • Number of events 1
|
0.00%
0/67
|
Other adverse events
| Measure |
Ropinirole
Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
|
Placebo
Subjects who took no investigational product.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
32.5%
64/197
|
7.5%
5/67
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
14/197
|
0.00%
0/67
|
|
General disorders
Fatigue
|
12.7%
25/197
|
6.0%
4/67
|
|
Nervous system disorders
Dizziness
|
8.6%
17/197
|
3.0%
2/67
|
|
Nervous system disorders
Headache
|
19.8%
39/197
|
13.4%
9/67
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER