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The Effects Of Ropinirole On Mood Or Mild Depression In Patients With Moderate To Severe Restless Legs Syndrome

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ClinicalTrials.gov Identifier: NCT00357097
Recruitment Status : Completed
First Posted : July 27, 2006
Results First Posted : September 16, 2009
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Restless Legs Syndrome
Moderate to Severe Idiopathic Restless Legs Syndrome (RLS)
Intervention Drug: Ropinirole
Enrollment 240
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description 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. Subjects who took no investigational product.
Period Title: Overall Study
Started 199 [1] 67
Completed 145 38
Not Completed 54 29
Reason Not Completed
Did not meet inclusion criteria             5             3
Adverse Event             34             6
Withdrawal by Subject             8             7
Non-compliance             1             2
Lack of Efficacy             2             8
Met Exclusion Criteria             3             1
Other             1             1
Increase of RLS Symptoms             0             1
[1]
199 were randomized. Only 198 took investigational product.
Arm/Group Title Ropinirole Placebo Total
Hide Arm/Group Description 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. Subjects who took no investigational product. Total of all reporting groups
Overall Number of Baseline Participants 198 67 265
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 198 participants 67 participants 265 participants
58.2  (11.4) 59.5  (11.3) 58.5  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 198 participants 67 participants 265 participants
Female
144
  72.7%
45
  67.2%
189.0
Male
54
  27.3%
22
  32.8%
76.0
1.Primary Outcome
Title Average Change of the MADRS (Montgomery-Asberg Depression Rating Scale) Total Score From Baseline to Final Visit After 12 Weeks of Treatment
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 171 60
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-10.1  (7.3) -6.5  (7.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropinirole, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.6
Confidence Interval 95%
-5.6 to -1.6
Estimation Comments Mean difference = Ropinirole minus Placebo. Used adjusted change from baseline.
2.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 91 29
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-12.5  (8.0) -8.8  (9.2)
3.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 166 55
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-8.2  (5.5) -5.5  (6.4)
4.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 93 33
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-9.6  (5.9) -7.2  (6.6)
5.Secondary Outcome
Title Average Change of the Beck Depression Inventory (BDI) Total Score From Baseline to Final Visit After 12 Weeks of Treatment
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 169 60
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-8.6  (7.0) -6.5  (7.8)
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 75 28
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-10.9  (7.9) -9.9  (9.0)
7.Secondary Outcome
Title Percentage of Participants With at Least Moderate Depression (MADRS Score >= 18) at Baseline and in Week 12
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at week 12).
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 171 60
Measure Type: Number
Unit of Measure: Percentage of Participants
11.7 23.3
8.Secondary Outcome
Title Percentage of Participants With at Least Moderate Depression (HAM-D >= 15) at Baseline and in Week 12
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 168 56
Measure Type: Number
Unit of Measure: Percentage of Participants
10.7 26.8
9.Secondary Outcome
Title Percentage of Participants (“Responder”) With a Decrease of MADRS Total Score of at Least 6 Points After 12 Weeks Compared to Baseline
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (mITT): All treated patients with MADRS score at baseline and post baseline (i.e., at visit 4 and/or 5).
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 171 60
Measure Type: Number
Unit of Measure: Percentage of Participants
74.9 48.3
10.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 91 29
Measure Type: Number
Unit of Measure: Percentage of Participants
80.2 58.6
11.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 93 34
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-11.6  (7.7) -7.6  (8.1)
12.Secondary Outcome
Title 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)
Hide Description 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).
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 90 31
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-9.2  (5.6) -6.5  (7.0)
13.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 91 34
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-10.4  (6.8) -7.2  (8.2)
14.Secondary Outcome
Title Change in Average International Restless Legs Scale for Severity (IRLS) Scores in All Participants From Baseline to After 1, 4, and 12 Weeks
Hide Description 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
Time Frame Baseline, Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 171 60
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Change from Baseline after 1 Week -7.7  (8.0) -4.1  (5.4)
Change from Baseline after 4 Weeks -14.0  (9.2) -8.6  (8.5)
Change from Baseline after 12 Weeks -14.6  (9.2) -10.2  (10.6)
15.Secondary Outcome
Title Percentage of Participants With a Decrease of International Restless Legs Scale (IRLS) Scores of at Least 6 Points After 1, 4 and 12 Weeks
Hide Description 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
Time Frame Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 171 60
Measure Type: Number
Unit of Measure: Percentage of Participants
1 Week 52.6 28.3
4 Weeks 80.7 58.3
12 Weeks 84.8 61.7
16.Secondary Outcome
Title Percentage of Participants With “Much Improved” or “Very Much Improved” on the Clinical Global Impression-Global Improvement Scale After 1, 4 and 12 Weeks
Hide Description 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.
Time Frame Week 1, Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 171 60
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 1 35.1 15.0
Week 4 66.7 40.0
Week 12 64.3 46.7
17.Secondary Outcome
Title Change From Average Baseline Score of Subscale of “Somnolence” in the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks
Hide Description 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.
Time Frame Baseline and after Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 171 59
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-12.5  (19.4) -10.2  (19.9)
18.Secondary Outcome
Title Change From Average Baseline Scores of Subscale “Sleep Disturbance” of the Medical Outcomes Study Sleep Scale (MOS-SS) to Final Visit After 12 Weeks
Hide Description 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.
Time Frame Baseline and after Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 167 59
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
-30.5  (24.5) -15.8  (27.6)
19.Secondary Outcome
Title Change From Average Baseline Scores of Subscale “Sleep Adequacy” of the Medical Outcomes Study Sleep Scale (MOS-SS)to Final Visit After 12 Weeks
Hide Description 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.
Time Frame Baseline and after Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 170 59
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
34.0  (30.6) 15.6  (36.2)
20.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Baseline and after Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All patients of the safety population with any psychometric data at baseline (within a single questionnaire)
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description:
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.
Subjects who took no investigational product.
Overall Number of Participants Analyzed 170 59
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
1.3  (1.3) 0.5  (1.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ropinirole Placebo
Hide Arm/Group Description 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. Subjects who took no investigational product.
All-Cause Mortality
Ropinirole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ropinirole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4      0    
Gastrointestinal disorders     
Nausea  1  1/197 (0.51%)  0/67 (0.00%) 
Vomiting  1  1/197 (0.51%)  0/67 (0.00%) 
Infections and infestations     
Bronchitis  1  1/197 (0.51%)  1 0/67 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion Missed  1  1/197 (0.51%)  1 0/67 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Back Pain  1  1/197 (0.51%)  0/67 (0.00%) 
Pulmonary Embolism  1  1/197 (0.51%)  0/67 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ropinirole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   134      20    
Gastrointestinal disorders     
Nausea  1  64/197 (32.49%)  5/67 (7.46%) 
Vomiting  1  14/197 (7.11%)  0/67 (0.00%) 
General disorders     
Fatigue  1  25/197 (12.69%)  4/67 (5.97%) 
Nervous system disorders     
Dizziness  1  17/197 (8.63%)  2/67 (2.99%) 
Headache  1  39/197 (19.80%)  9/67 (13.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00357097     History of Changes
Other Study ID Numbers: RRL106721
First Submitted: July 25, 2006
First Posted: July 27, 2006
Results First Submitted: December 12, 2008
Results First Posted: September 16, 2009
Last Update Posted: June 7, 2012