Trial Outcomes & Findings for Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome (NCT NCT00530790)
NCT ID: NCT00530790
Last Updated: 2018-09-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Weeks 1 - 12 Treatment Period
Results posted on
2018-09-26
Participant Flow
Participant milestones
| Measure |
Ropinirole CR-RLS
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
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|---|---|
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Overall Study
STARTED
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35
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Overall Study
COMPLETED
|
30
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|
Overall Study
NOT COMPLETED
|
5
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Reasons for withdrawal
| Measure |
Ropinirole CR-RLS
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
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|---|---|
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Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
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Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome
Baseline characteristics by cohort
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
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|---|---|
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Age, Continuous
|
48.2 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
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35 Number of participants
n=5 Participants
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PRIMARY outcome
Timeframe: Weeks 1 - 12 Treatment PeriodPopulation: Safety Population consisting of the subjects who took at least one dose of the study medication.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
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|---|---|
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Drug Related Adverse Events-On-Therapy
Thirst
|
1 Number of Events
|
|
Drug Related Adverse Events-On-Therapy
Subjects with any Adverse Events
|
29 Number of Events
|
|
Drug Related Adverse Events-On-Therapy
Nausea
|
14 Number of Events
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|
Drug Related Adverse Events-On-Therapy
Somnolence
|
5 Number of Events
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Drug Related Adverse Events-On-Therapy
Vomiting
|
5 Number of Events
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Drug Related Adverse Events-On-Therapy
Hypersomnia
|
3 Number of Events
|
|
Drug Related Adverse Events-On-Therapy
Diarrhea
|
2 Number of Events
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|
Drug Related Adverse Events-On-Therapy
Dizziness
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2 Number of Events
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Drug Related Adverse Events-On-Therapy
Dyspepsia
|
2 Number of Events
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|
Drug Related Adverse Events-On-Therapy
Fatigue
|
2 Number of Events
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|
Drug Related Adverse Events-On-Therapy
Stomach discomfort
|
2 Number of Events
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|
Drug Related Adverse Events-On-Therapy
Abdominal pain
|
1 Number of Events
|
|
Drug Related Adverse Events-On-Therapy
Anemia
|
1 Number of Events
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|
Drug Related Adverse Events-On-Therapy
Insomnia
|
1 Number of Events
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Drug Related Adverse Events-On-Therapy
Irritability
|
1 Number of Events
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Drug Related Adverse Events-On-Therapy
Malaise
|
1 Number of Events
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|
Drug Related Adverse Events-On-Therapy
Middle Insomnia
|
1 Number of Events
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|
Drug Related Adverse Events-On-Therapy
Motion Sickness
|
1 Number of Events
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|
Drug Related Adverse Events-On-Therapy
Palpitations
|
1 Number of Events
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PRIMARY outcome
Timeframe: Baseline - Week 13 (Follow-up)Population: Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).
Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
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|---|---|
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Haematology Clinical Lab Values Change From Baseline
Hemoglobin (G/L) - week 4
|
-1.2 Varied Standard Units of Measure
Standard Deviation 6.97
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|
Haematology Clinical Lab Values Change From Baseline
Hemoglobin (G/L) - week 8
|
-2.7 Varied Standard Units of Measure
Standard Deviation 8.79
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|
Haematology Clinical Lab Values Change From Baseline
Hemoglobin (G/L) - week 12
|
-1.0 Varied Standard Units of Measure
Standard Deviation 4.84
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Haematology Clinical Lab Values Change From Baseline
Hemoglobin (G/L) - week 12/EW
|
-0.8 Varied Standard Units of Measure
Standard Deviation 4.69
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Haematology Clinical Lab Values Change From Baseline
Hemoglobin (G/L)- week 13
|
-2.2 Varied Standard Units of Measure
Standard Deviation 7.30
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Haematology Clinical Lab Values Change From Baseline
Hematocrit (SI) - week 4
|
-0.0033 Varied Standard Units of Measure
Standard Deviation 0.01972
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Haematology Clinical Lab Values Change From Baseline
Hematocrit (SI) - week 8
|
-0.0074 Varied Standard Units of Measure
Standard Deviation 0.02470
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Haematology Clinical Lab Values Change From Baseline
Hematocrit (SI) - week 12
|
-0.0021 Varied Standard Units of Measure
Standard Deviation 0.01174
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Haematology Clinical Lab Values Change From Baseline
Hematocrit (SI) - week 12/EW
|
-0.0016 Varied Standard Units of Measure
Standard Deviation 0.01148
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Haematology Clinical Lab Values Change From Baseline
Hematocrit (SI) - week 13
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-0.0063 Varied Standard Units of Measure
Standard Deviation 0.01929
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Haematology Clinical Lab Values Change From Baseline
Platelet Count (GI/L) - week 4
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14.5 Varied Standard Units of Measure
Standard Deviation 26.86
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Haematology Clinical Lab Values Change From Baseline
Platelet Count (GI/L) - week 8
|
11.7 Varied Standard Units of Measure
Standard Deviation 27.92
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Haematology Clinical Lab Values Change From Baseline
Platelet Count (GI/L) - week 12
|
8.5 Varied Standard Units of Measure
Standard Deviation 22.79
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|
Haematology Clinical Lab Values Change From Baseline
Platelet Count (GI/L) - week 12/EW
|
8.8 Varied Standard Units of Measure
Standard Deviation 21.74
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|
Haematology Clinical Lab Values Change From Baseline
Platelet Count (GI/L) - week 13
|
10.7 Varied Standard Units of Measure
Standard Deviation 41.48
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Haematology Clinical Lab Values Change From Baseline
Red Blood Cell Count (TI/L) - week 4
|
-0.043 Varied Standard Units of Measure
Standard Deviation 0.2139
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Haematology Clinical Lab Values Change From Baseline
Red Blood Cell Count (TI/L) - week 8
|
-0.084 Varied Standard Units of Measure
Standard Deviation 0.2701
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Haematology Clinical Lab Values Change From Baseline
Red Blood Cell Count (TI/L) - week 12
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-0.015 Varied Standard Units of Measure
Standard Deviation 0.1469
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Haematology Clinical Lab Values Change From Baseline
Red Blood Cell Count (TI/L) - week 12/EW
|
-0.011 Varied Standard Units of Measure
Standard Deviation 0.1411
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Haematology Clinical Lab Values Change From Baseline
Red Blood Cell Count (TI/L) - week 13
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-0.050 Varied Standard Units of Measure
Standard Deviation 0.2140
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Haematology Clinical Lab Values Change From Baseline
White Blood Cell Count (GI/L) - week 4
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-0.191 Varied Standard Units of Measure
Standard Deviation 1.1655
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|
Haematology Clinical Lab Values Change From Baseline
White Blood Cell Count (GI/L) - week 8
|
-0.268 Varied Standard Units of Measure
Standard Deviation 1.8694
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|
Haematology Clinical Lab Values Change From Baseline
White Blood Cell Count (GI/L) - week 12
|
-0.577 Varied Standard Units of Measure
Standard Deviation 1.4972
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|
Haematology Clinical Lab Values Change From Baseline
White Blood Cell Count (GI/L) - week 12/EW
|
-0.516 Varied Standard Units of Measure
Standard Deviation 1.4407
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|
Haematology Clinical Lab Values Change From Baseline
White Blood Cell Count (GI/L) - week 13
|
-0.624 Varied Standard Units of Measure
Standard Deviation 1.4914
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PRIMARY outcome
Timeframe: Baseline - Week 13 (Follow-up)Population: Safety Population (Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 (Follow-up) = 35 subjects whose labs were evaluated).
Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
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|---|---|
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Blood Chemistry Clinical Lab Values Change From Baseline
Cholesterol (MMOL/L) - week 12/EW
|
0.146540 Varied Standard Units of Measure
Standard Deviation 0.5494743
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Albumin (G/L) - week 4
|
-1.0 Varied Standard Units of Measure
Standard Deviation 2.35
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Albumin (G/L) - week 8
|
-1.4 Varied Standard Units of Measure
Standard Deviation 2.64
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Albumin (G/L) - week 12
|
-0.7 Varied Standard Units of Measure
Standard Deviation 2.34
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Albumin (G/L) - week 12/EW
|
-0.6 Varied Standard Units of Measure
Standard Deviation 2.28
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Albumin (G/L) - week 13
|
-1.3 Varied Standard Units of Measure
Standard Deviation 2.33
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Alkaline Phosphatase (IU/L) - week 4
|
5.2 Varied Standard Units of Measure
Standard Deviation 30.53
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Alkaline Phosphatase (IU/L) - week 8
|
4.2 Varied Standard Units of Measure
Standard Deviation 26.94
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Alkaline Phosphatase (IU/L) - week 12
|
13.2 Varied Standard Units of Measure
Standard Deviation 29.35
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Alkaline Phosphatase (IU/L) - week 12/EW
|
13.4 Varied Standard Units of Measure
Standard Deviation 28.52
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Alkaline Phosphatase (IU/L) - week 13
|
16.0 Varied Standard Units of Measure
Standard Deviation 36.45
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Alanine Amino Transferase (IU/L) - week 4
|
-0.3 Varied Standard Units of Measure
Standard Deviation 3.80
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Alanine Amino Transferase (IU/L) - week 8
|
-0.7 Varied Standard Units of Measure
Standard Deviation 5.08
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Alanine Amino Transferase (IU/L) - week 12
|
1.7 Varied Standard Units of Measure
Standard Deviation 4.66
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Alanine Amino Transferase - week 12/EW
|
1.8 Varied Standard Units of Measure
Standard Deviation 4.56
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Alanine Amino Transferase - week 13
|
1.4 Varied Standard Units of Measure
Standard Deviation 6.36
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Aspartate Amino Transferase(IU/L) - week 4
|
0.4 Varied Standard Units of Measure
Standard Deviation 4.55
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Aspartate Amino Transferase (IU/L) - week 8
|
-0.2 Varied Standard Units of Measure
Standard Deviation 4.07
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Aspartate Amino Transferase (IU/L) - week 12
|
1.3 Varied Standard Units of Measure
Standard Deviation 4.57
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Aspartate Amino Transferase (IU/L) - week 12/EW
|
1.5 Varied Standard Units of Measure
Standard Deviation 4.51
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Aspartate Amino Transferase (IU/L) - week 13
|
0.6 Varied Standard Units of Measure
Standard Deviation 4.35
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Bilirubin (UMOL/L) - week 4
|
0.147 Varied Standard Units of Measure
Standard Deviation 3.1686
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Bilirubin (UMOL/L) - week 8
|
-0.588 Varied Standard Units of Measure
Standard Deviation 2.5180
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Bilirubin (UMOL/L) - week 12
|
0.513 Varied Standard Units of Measure
Standard Deviation 3.4244
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Bilirubin (UMOL/L) - week 12/EW
|
0.311 Varied Standard Units of Measure
Standard Deviation 3.3513
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Bilirubin (UMOL/L) - week 13
|
-1.173 Varied Standard Units of Measure
Standard Deviation 3.7959
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Blood Urea Nitrogen (MMOL/L) - week 4
|
-0.14382 Varied Standard Units of Measure
Standard Deviation 1.079245
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|
Blood Chemistry Clinical Lab Values Change From Baseline
Blood Urea Nitrogen (MMOL/L) - week 8
|
-0.06024 Varied Standard Units of Measure
Standard Deviation 0.862798
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Blood Urea Nitrogen (MMOL/L) - week 12
|
0.25704 Varied Standard Units of Measure
Standard Deviation 1.076664
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Blood Urea Nitrogen (MMOL/L) - week 12/EW
|
0.30399 Varied Standard Units of Measure
Standard Deviation 1.043047
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Blood Urea Nitrogen (MMOL/L) - week 13
|
0.32334 Varied Standard Units of Measure
Standard Deviation 0.974457
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Cholesterol (MMOL/L) - week 4
|
-0.093835 Varied Standard Units of Measure
Standard Deviation 0.5322345
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Cholesterol (MMOL/L) - week 8
|
-0.190717 Varied Standard Units of Measure
Standard Deviation 0.4337538
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Cholesterol (MMOL/L) - week 12
|
0.151712 Varied Standard Units of Measure
Standard Deviation 0.5674075
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Cholesterol - week 13
|
-0.107873 Varied Standard Units of Measure
Standard Deviation 0.5638668
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Chloride(MMOL/L) - week 4
|
0.1 Varied Standard Units of Measure
Standard Deviation 1.78
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Chloride (MMOL/L) - week 8
|
0.3 Varied Standard Units of Measure
Standard Deviation 2.07
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Chloride (MMOL/L) - week 12
|
-0.3 Varied Standard Units of Measure
Standard Deviation 1.81
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Chloride (MMOL/L) - week 12/EW
|
-0.2 Varied Standard Units of Measure
Standard Deviation 1.92
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Chloride (MMOL/L) - week 13
|
-0.1 Varied Standard Units of Measure
Standard Deviation 2.30
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Lactate Dehydrogenase (IU/L) - week 4
|
0.3 Varied Standard Units of Measure
Standard Deviation 22.02
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Lactate Dehydrogenase (IU/L) - week 8
|
-1.3 Varied Standard Units of Measure
Standard Deviation 16.74
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Lactate Dehydrogenase (IU/L) - week 12
|
2.0 Varied Standard Units of Measure
Standard Deviation 25.96
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Lactate Dehydrogenase (IU/L) - week 12/EW
|
2.7 Varied Standard Units of Measure
Standard Deviation 25.06
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Lactate Dehydrogenase (IU/L) - week 13
|
-2.2 Varied Standard Units of Measure
Standard Deviation 18.78
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Sodium (MMOL/L) - week 4
|
-0.4 Varied Standard Units of Measure
Standard Deviation 1.37
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Sodium (MMOL/L) - week 8
|
-0.2 Varied Standard Units of Measure
Standard Deviation 1.36
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Sodium (MMOL/L) - week 12
|
0.0 Varied Standard Units of Measure
Standard Deviation 1.11
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Sodium (MMOL/L) - week 12/EW
|
-0.0 Varied Standard Units of Measure
Standard Deviation 1.07
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Sodium (MMOL/L) - week 13
|
-0.2 Varied Standard Units of Measure
Standard Deviation 1.29
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Prolactin (MCG/L) - week 4
|
0.80 Varied Standard Units of Measure
Standard Deviation 7.003
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Prolactin (MCG/L) - week 8
|
0.51 Varied Standard Units of Measure
Standard Deviation 7.229
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Prolactin (MCG/L) - week 12
|
0.20 Varied Standard Units of Measure
Standard Deviation 6.770
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Prolactin (MCG/L) - week 12/EW
|
0.22 Varied Standard Units of Measure
Standard Deviation 6.466
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Prolactin (MCG/L) - week 13
|
1.14 Varied Standard Units of Measure
Standard Deviation 7.144
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Protein (G/L) - week 4
|
-1.1 Varied Standard Units of Measure
Standard Deviation 3.73
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Protein (G/L) - week 8
|
-1.7 Varied Standard Units of Measure
Standard Deviation 4.03
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Protein (G/L) - week 12
|
-0.8 Varied Standard Units of Measure
Standard Deviation 3.32
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Protein (G/L) - week 12/EW
|
-0.8 Varied Standard Units of Measure
Standard Deviation 3.20
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Total Protein (G/L) - week 13
|
-2.2 Varied Standard Units of Measure
Standard Deviation 3.45
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatine Phosphokinase (IU/L) - week 4
|
72.3 Varied Standard Units of Measure
Standard Deviation 533.72
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatine Phosphokinase (IU/L) - week 8
|
-15.8 Varied Standard Units of Measure
Standard Deviation 100.86
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatine Phosphokinase (IU/L) - week 12
|
-0.6 Varied Standard Units of Measure
Standard Deviation 115.92
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatine Phosphokinase (IU/L) - week 12/EW
|
-0.2 Varied Standard Units of Measure
Standard Deviation 110.40
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatine Phosphokinase (IU/L) - week 13
|
-1.9 Varied Standard Units of Measure
Standard Deviation 124.63
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatinine (UMOL/L) - week 4
|
1.3134 Varied Standard Units of Measure
Standard Deviation 4.76710
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatinine (UMOL/L) - week 8
|
0.5801 Varied Standard Units of Measure
Standard Deviation 7.23972
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatinine (UMOL/L) - week 12
|
1.0019 Varied Standard Units of Measure
Standard Deviation 4.73343
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatinine (UMOL/L) - week 12/EW
|
1.0447 Varied Standard Units of Measure
Standard Deviation 4.60113
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Creatinine (UMOL/L) - week 13
|
1.6417 Varied Standard Units of Measure
Standard Deviation 4.96904
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Gamma Glutamyl Transferase (IU/L) - week 4
|
1.5 Varied Standard Units of Measure
Standard Deviation 17.56
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Gamma Glutamyl Transferase (IU/L) - week 8
|
-1.4 Varied Standard Units of Measure
Standard Deviation 11.68
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Gamma Glutamyl Transferase (IU/L) - week 12
|
1.9 Varied Standard Units of Measure
Standard Deviation 14.56
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Gamma Glutamyl Transferase (IU/L) - week 12/EW
|
2.6 Varied Standard Units of Measure
Standard Deviation 14.26
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Gamma Glutamyl Tranferase (IU/L) - week 13
|
0.1 Varied Standard Units of Measure
Standard Deviation 10.10
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Potassium (MMOL/L) - week 4
|
0.07 Varied Standard Units of Measure
Standard Deviation 0.280
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Potassium (MMOL/L) - week 8
|
0.05 Varied Standard Units of Measure
Standard Deviation 0.363
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Potassium (MMOL/L) - week 12
|
0.09 Varied Standard Units of Measure
Standard Deviation 0.305
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Potassium (MMOL/L) - week 12/EW
|
0.10 Varied Standard Units of Measure
Standard Deviation 0.293
|
|
Blood Chemistry Clinical Lab Values Change From Baseline
Potassium (MMOL/L) - week 13
|
0.06 Varied Standard Units of Measure
Standard Deviation 0.308
|
PRIMARY outcome
Timeframe: Baseline - Week 13 (Follow-up)Population: Safety Population (Baseline, Week 4 = 35 subjects, Week 8 = 32 subjects, Week 12 = 30 subjects, Week 12/EW = 33 subjects, Week 13 \[Follow-up\] = 35 subjects evaluated).
Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12/EW: Neg Value
|
32 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12/EW: Trace
|
1 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12/EW: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12/EW: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12/EW: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - Baseline: Neg Value
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - Baseline: Trace
|
35 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - Baseline: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - Baseline: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - Baseline: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 4: Neg Value
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 4: Trace
|
35 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 4: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 4: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 4: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 8: Neg Value
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 8: Trace
|
32 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 8: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 8: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 8: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12: Neg Value
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12: Trace
|
30 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12/EW: Neg Value
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12/EW: Trace
|
33 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12/EW: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12/EW: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 12/EW: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 13: Neg Value
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 13: Trace
|
35 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 13: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 13: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Urobilinogen - week 13: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Baseline: Neg Value
|
34 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Baseline: Trace
|
1 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Baseline: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Baseline: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Baseline: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 4: Neg Value
|
35 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 4: Trace
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 4: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 4: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 4: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 8: Neg Value
|
31 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 8: Trace
|
1 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 8: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 8: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 8: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12: Neg Value
|
30 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12: Trace
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12/EW: Neg Value
|
33 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12/EW: Trace
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12/EW: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12/EW: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 12/EW: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 13: Neg Value
|
35 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 13: Trace
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 13: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 13: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Protein - Week 13: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Baseline: Neg Value
|
27 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Baseline: Trace
|
5 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Baseline: +1
|
3 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Baseline: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Baseline: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 4: Neg Value
|
20 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 4: Trace
|
7 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 4: +1
|
6 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 4: +2
|
2 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 4: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 8: Neg Value
|
25 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 8: Trace
|
3 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 8: +1
|
3 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 8: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 8: +3
|
1 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12: Neg Value
|
23 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12: Trace
|
4 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12: +1
|
2 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12: +2
|
1 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12/EW: Neg Value
|
25 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12/EW: Trace
|
5 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12/EW: +1
|
2 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12/EW: +2
|
1 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 12/EW: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 13: Neg Value
|
26 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 13: Trace
|
3 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 13: +1
|
6 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 13: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Occult Blood - Week 13: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Baseline: Neg Value
|
35 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Baseline: Trace
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Baseline: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Baseline: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Baseline: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 4: Neg Value
|
34 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 4: Trace
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 4: +1
|
1 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 4: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 4: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 8: Neg Value
|
31 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 8: Trace
|
1 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 8: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 8: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 8: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12: Neg Value
|
29 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12: Trace
|
1 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 12: +3
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 13: Neg Value
|
35 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 13: Trace
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 13: +1
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 13: +2
|
0 Participants
|
|
Urinalysis Clinical Lab Values
Urine Glucose - Week 13: +3
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, 8, 12, 13 (Follow-up)Population: Safety Population - (Baseline = 35 subjects, Week 4 = 33 subjects, Week 8 = 31 subjects, Week 12/EW = 33 subjects and Week 13 \[Follow-up\] = 35 subjects evaluated).
Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Baseline: ANCS
|
5 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 8: N
|
24 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 8: ANCS
|
2 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 8: N
|
2 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 8: ANCS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 12/EW: N
|
27 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 12/EW: N
|
4 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 12/EW: ANCS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 13: ANCS
|
2 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 13: ACS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 13: N
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Baseline: N
|
29 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Baseline: ANCS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Baseline: ACS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Baseline: N
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Baseline: ACS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Baseline: N
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline; ACS; Baseline: ANCS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS ; Baseline: ACS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 4: N
|
27 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 4: ANCS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 4: ACS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 4: N
|
2 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 4: ANCS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 4: ACS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 4: N
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 4: ANCS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 4: ACS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 8: ACS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 8: ACS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 8: N
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 8: ANCS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 8: ACS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 12/EW: ANCS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 12/EW: ACS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 12/EW: ACS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 12/EW: N
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 12/EW: ANCS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 12/EW: ACS
|
1 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 13: N
|
27 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: N; Week 13: ACS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 13: N
|
2 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ANCS; Week 13: ANCS
|
2 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 13: ANCS
|
0 Participants
|
|
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Baseline: ACS; Week 13: ACS
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12/EWPopulation: Safety Population
Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=33 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Vital Signs and Body Weight Change From Baseline
Standing Diastolic BP (mmHg)
|
0.8 Varied Standard Units of Measure
Standard Deviation 7.64
|
|
Vital Signs and Body Weight Change From Baseline
Weight (Kg)
|
0.5 Varied Standard Units of Measure
Standard Deviation 1.33
|
|
Vital Signs and Body Weight Change From Baseline
Semi-Supine Systolic BP (mmHg)
|
2.7 Varied Standard Units of Measure
Standard Deviation 10.68
|
|
Vital Signs and Body Weight Change From Baseline
Semi-Supine Diastolic BP (mmHg)
|
2.6 Varied Standard Units of Measure
Standard Deviation 7.25
|
|
Vital Signs and Body Weight Change From Baseline
Semi-Supine Pulse Rate (bpm)
|
0.8 Varied Standard Units of Measure
Standard Deviation 9.11
|
|
Vital Signs and Body Weight Change From Baseline
Standing Systolic BP (mmHg)
|
-0.7 Varied Standard Units of Measure
Standard Deviation 10.86
|
|
Vital Signs and Body Weight Change From Baseline
Standing Pulse Rate (bpm)
|
1.1 Varied Standard Units of Measure
Standard Deviation 9.94
|
|
Vital Signs and Body Weight Change From Baseline
Orthostatic Systolic BP (mmHg)
|
-1.5 Varied Standard Units of Measure
Standard Deviation 8.50
|
|
Vital Signs and Body Weight Change From Baseline
Orthostatic Diastolic BP (mmHg)
|
4.3 Varied Standard Units of Measure
Standard Deviation 5.58
|
|
Vital Signs and Body Weight Change From Baseline
Orthostatic Pulse Rate (bpm)
|
9.2 Varied Standard Units of Measure
Standard Deviation 9.15
|
SECONDARY outcome
Timeframe: Baseline and after Week 12Population: Full Analysis Set: Subjects entered to the treatment period, except for those not fulfilling the major registration criteria, those who did not take even one dose of the study medication, and those for whom no observation data were available after starting the study treatment. Method for missing data is Last Observation Carried Forward (LOCF).
The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score
IRLS assessment Score - week 0
|
25.3 Points on a scale
Standard Deviation 4.42
|
|
Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score
IRLS assessment Score - week 12
|
6.0 Points on a scale
Standard Deviation 7.5
|
|
Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score
Change from Baseline at week 12
|
-19.3 Points on a scale
Standard Deviation 7.68
|
SECONDARY outcome
Timeframe: Baseline - Final assessment pointPopulation: Full Analysis Set Population (Baseline, Weeks 1, 2, 3, 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Weeks 10 and 12 = 30 subjects; Final assessment point = 35 subjects). Method of Missing Data = LOCF.
The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7).
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Baseline - Normal
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Baseline - Borderline
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Baseline - Mildly
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Baseline - Moderately
|
13 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Baseline - Markedly
|
13 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Baseline - Severely
|
9 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 1 - Normal
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 1 - Borderline
|
3 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 1 - Mildly
|
10 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 1 - Moderately
|
16 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 1 - Markedly
|
4 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 1 - Severely
|
2 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 2 - Normal
|
3 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 2 - Borderline
|
7 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 2 - Mildly
|
12 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 2 - Moderately
|
10 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 2 - Markedly
|
2 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 2 - Severely
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 3 - Normal
|
11 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 3 - Borderline
|
7 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 3 - Mildly
|
8 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 3 - Moderately
|
7 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 3 - Markedly
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 3 - Severely
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 4 - Normal
|
9 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 4 - Borderline
|
9 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 4 - Mildly
|
10 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 4 - Moderately
|
5 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 4 - Markedly
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 4 - Severely
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 5 - Normal
|
11 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 5 - Borderline
|
6 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 5 - Mildly
|
11 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 5 - Moderately
|
4 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 5 - Markedly
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 5 - Severely
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 6 - Normal
|
13 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 6 - Borderline
|
4 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 6 - Mildly
|
11 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 6 - Moderately
|
4 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 6 - Markedly
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 6 - Severely
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 8 - Normal
|
10 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 8 - Borderline
|
10 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 8 - Mildly
|
8 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 8 - Moderately
|
3 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 8 - Markedly
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 8 - Severely
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 10 - Normal
|
15 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 10 - Borderline
|
5 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 10 - Mildly
|
8 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 10 - Moderately
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 10 - Markedly
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 10 - Severely
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 12 - Normal
|
16 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 12 - Borderline
|
3 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 12 - Mildly
|
10 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 12 - Moderately
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 12 - Markedly
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Week 12 - Severely
|
0 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Final assessment point - Normal
|
17 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Final assessment point - Borderline
|
3 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Final assessment point - Mildly
|
12 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Final assessment point - Moderately
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Final assessment point - Markedly
|
1 Participants
|
|
Clinical Global Impression Scale - Severity of Illness (CGI-S)
Final assessment point - Severely
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline - Final assessment pointPopulation: Full Analysis Set Population (Weeks 1, 2, 3, and 4 = 35 subjects; Weeks 5 and 6 = 33 subjects; Week 8 = 32 subjects; Week 10, 12 = 30 subjects; Final assessment point = 35 subjects). Method for missing date is LOCF.
CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7).
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 1 - Very Much Improved
|
4 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 1 - Much Improved
|
12 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 1 - Minimally Improved
|
13 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 1 - No Change
|
6 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 2 - Very Much Improved
|
15 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 2 - Much Improved
|
9 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 2 - Minimally Improved
|
9 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 2 - No Change
|
2 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 3 - Very Much Improved
|
21 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 3 - Much Improved
|
7 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 3 - Minimally Improved
|
6 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 3 - No Change
|
1 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 4 - Very Much Improved
|
21 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 4 - Much Improved
|
7 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 4 - Minimally Improved
|
6 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 4 - No Change
|
1 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 5 - Very Much Improved
|
21 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 5 - Much Improved
|
6 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 5 - Minimally Improved
|
6 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 5 - No Change
|
0 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 6 - Very Much Improved
|
22 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 6 - Much Improved
|
7 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 6 - Minimally Improved
|
4 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 6 - No Change
|
0 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 8 - Very Much Improved
|
24 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 8 - Much Improved
|
6 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 8 - Minimally Improved
|
2 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 8 - No Change
|
0 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 10 - Very Much Improved
|
22 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 10 - Much Improved
|
6 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 10 - Minimally Improved
|
2 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 10 - No Change
|
0 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 12 - Very Much Improved
|
25 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 12 - Much Improved
|
4 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 12 - Minimally Improved
|
0 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Week 12 - No Change
|
1 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Final assessment point - Very Much Improved
|
27 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Final assessment point - Much Improved
|
5 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Final assessment point - Minimally Improved
|
1 Participants
|
|
Clinical Global Impression Global Improvement (CGI-GI)
Final assessment point - No Change
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline - Week 12/EWPopulation: Full Analysis Set(FAS)
The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score \> 5 is considered to be suggestive of significant sleep disturbance.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score
PSQI Total Score at Baseline
|
9.4 Points on a scale
Standard Deviation 3.20
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score
PSQI Total Score at Week 12/EW
|
5.4 Points on a scale
Standard Deviation 2.89
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score
Change from Baseline at Week 12/EW
|
-4.2 Points on a scale
Standard Deviation 3.94
|
SECONDARY outcome
Timeframe: Baseline - Week 12/EWPopulation: Full Analysis Set(FAS)
The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score \> 5 is considered to be suggestive of significant sleep disturbance.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Quality - Baseline
|
2.0 Points on a scale
Standard Deviation 0.62
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Quality - Week 12/EW
|
1.2 Points on a scale
Standard Deviation 0.77
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Quality - Change from Baseline
|
-0.9 Points on a scale
Standard Deviation 0.78
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Duration getting to sleep - Baseline
|
2.0 Points on a scale
Standard Deviation 1.04
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Duration getting to sleep - Week 12/EW
|
1.0 Points on a scale
Standard Deviation 0.88
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Duration getting to sleep - Change from Baseline
|
-1.1 Points on a scale
Standard Deviation 1.09
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Duration - Baseline
|
1.9 Points on a scale
Standard Deviation 0.77
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Duration - Week 12/EW
|
1.5 Points on a scale
Standard Deviation 0.79
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Duration - Change from Baseline
|
-0.4 Points on a scale
Standard Deviation 0.74
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Adequacy - Baseline
|
0.9 Points on a scale
Standard Deviation 1.11
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Adequacy - Week 12/EW
|
0.4 Points on a scale
Standard Deviation 0.70
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Adequacy - Change from Baseline
|
-0.6 Points on a scale
Standard Deviation 1.19
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Disturbance - Baseline
|
1.2 Points on a scale
Standard Deviation 0.43
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Disturbance - Week 12/EW
|
0.9 Points on a scale
Standard Deviation 0.55
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Sleep Disturbance - Change from Baseline
|
-0.3 Points on a scale
Standard Deviation 0.60
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Use of Sleeping pill - Baseline
|
0.4 Points on a scale
Standard Deviation 1.01
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Use of Sleeping pill - Week 12/EW
|
0.0 Points on a scale
Standard Deviation 0.00
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Use of Sleeping pill - Change from Baseline
|
-0.4 Points on a scale
Standard Deviation 1.03
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Somnolence - Baseline
|
1.0 Points on a scale
Standard Deviation 0.92
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Somnolence - Week 12/EW
|
0.5 Points on a scale
Standard Deviation 0.62
|
|
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Somnolence - Change from Baseline
|
-0.5 Points on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline and Week 12/EWPopulation: Full Analysis Set(FAS)
The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47
Outcome measures
| Measure |
Ropinirole CR-RLS
n=33 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score
RLSQOL Overall Life Impact Score - Baseline
|
65.29 Points on a scale
Standard Deviation 14.499
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score
RLSQOL Overall Life Impact Score - Week 12
|
89.09 Points on a scale
Standard Deviation 13.431
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score
Change from Baseline
|
23.94 Points on a scale
Standard Deviation 16.759
|
SECONDARY outcome
Timeframe: Baseline and Week 12/EWPopulation: Full Analysis Set
The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from "Not at all (0)" to "Extremely (4)." The assessment measures six identified mood factors: * Tension-Anxiety * Depression-Dejection * Anger-Hostility * Vigor-Activity * Fatigue-Inertia * Confusion-Bewilderment
Outcome measures
| Measure |
Ropinirole CR-RLS
n=33 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)
POMS - Baseline
|
59.2 Points on a scale
Standard Deviation 21.59
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)
POMS - Week 12/EW
|
48.0 Points on a scale
Standard Deviation 18.69
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)
Change from Baseline
|
-10.4 Points on a scale
Standard Deviation 14.46
|
SECONDARY outcome
Timeframe: Baseline - Week 12/EWPopulation: FAS: Subpopulation: HADS Anxiety population, N = 15; HADS Depression population, N = 31. Patients in the FAS population who also have a baseline anxiety domain score of 8 or greater and patients with a baseline depression domain score of 8 or greater will be included in the HADS Anxiety Population and the HADS Depression Population, respectively.
Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety "0-21" and seven for depression "0-21". Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)
Anxiety-HADS Anxiety Population - Week 12/EW
|
7.7 Points on a scale
Standard Deviation 2.39
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)
Anxiety-HADS Anxiety Population - Baseline
|
9.3 Points on a scale
Standard Deviation 1.50
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)
Change from Baseline for Anxiety Population
|
-1.8 Points on a scale
Standard Deviation 2.58
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)
Depression-HADS Depression Population -Baseline
|
9.7 Points on a scale
Standard Deviation 1.42
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)
Depression-HADS Depression Population-Week 12/EW
|
9.5 Points on a scale
Standard Deviation 1.57
|
|
Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)
Change from Baseline for Depression Population
|
-0.1 Points on a scale
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: Pharmacokinetic (PK) Population: subjects who underwent blood sampling for measuring the trough plasma drug concentrations, excluding those who did not fulfill inclusion criteria, those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.
Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.
35 subjects who received 0.5 mg of Study drug
|
310.01 picograms/mL
Standard Deviation 188.460
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.
27subjects who received 1 mg of Study drug
|
500.97 picograms/mL
Standard Deviation 293.344
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.
11 subjects who received 2 mg of Study drug
|
968.36 picograms/mL
Standard Deviation 696.327
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.
2 subjects who received 3 mg of Study drug
|
1294.55 picograms/mL
Standard Deviation 442.861
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.
2 subjects who received 4 mg of Study drug
|
1198.10 picograms/mL
Standard Deviation 362.463
|
SECONDARY outcome
Timeframe: Weeks 1 -12Population: PK Population
Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.
35 subjects who received 0.5 mg of Study drug
|
324.65 picograms/mL
Standard Deviation 134.576
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.
2 subjects who received 3 mg of Study drug
|
1666.65 picograms/mL
Standard Deviation 325.764
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.
27 subjects who received 1 mg of Study drug
|
615.91 picograms/mL
Standard Deviation 259.145
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.
11 subjects who received 2 mg of Study drug
|
1320.31 picograms/mL
Standard Deviation 523.622
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.
2 subjects who received 4 mg of Study drug
|
2541.95 picograms/mL
Standard Deviation 198.202
|
SECONDARY outcome
Timeframe: Weeks 1-12Population: PK Population
Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.
Outcome measures
| Measure |
Ropinirole CR-RLS
n=35 Participants
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.
2 subjects who received 0.5 mg of Study drug
|
22.45 picograms/mL
Standard Deviation 3.465
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.
11 subjects who received 1 mg of Study drug
|
30.37 picograms/mL
Standard Deviation 10.227
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.
11 subjects who received 2 mg of Study drug
|
42.75 picograms/mL
Standard Deviation 17.286
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.
2 subjects who received 3 mg of Study drug
|
46.80 picograms/mL
Standard Deviation 8.202
|
|
Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.
2 subjects who received 4 mg of Study drug
|
72.05 picograms/mL
Standard Deviation 2.051
|
Adverse Events
Ropinirole CR-RLS
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ropinirole CR-RLS
n=35 participants at risk
Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
42.9%
15/35
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
34.3%
12/35
|
|
Psychiatric disorders
Somnolence
|
14.3%
5/35
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
5/35
|
|
General disorders
Dizziness
|
8.6%
3/35
|
|
Psychiatric disorders
Hypersomnia
|
8.6%
3/35
|
|
Blood and lymphatic system disorders
Anemia
|
5.7%
2/35
|
|
Gastrointestinal disorders
Constipation
|
5.7%
2/35
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
2/35
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
2/35
|
|
General disorders
Fatigue
|
5.7%
2/35
|
|
Infections and infestations
Gingivitis
|
5.7%
2/35
|
|
Gastrointestinal disorders
Stomach Discomfort
|
5.7%
2/35
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35
|
|
Gastrointestinal disorders
Abdominal Pain upper
|
2.9%
1/35
|
|
Gastrointestinal disorders
Abdominal tenderness
|
2.9%
1/35
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.9%
1/35
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/35
|
|
Investigations
Blood urine present
|
2.9%
1/35
|
|
Injury, poisoning and procedural complications
Chillblains
|
2.9%
1/35
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
2.9%
1/35
|
|
Gastrointestinal disorders
Gingival pain
|
2.9%
1/35
|
|
Psychiatric disorders
Initial insomnia
|
2.9%
1/35
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/35
|
|
General disorders
Irritability
|
2.9%
1/35
|
|
General disorders
Local Swelling
|
2.9%
1/35
|
|
General disorders
Malaise
|
2.9%
1/35
|
|
Psychiatric disorders
Middle insomnia
|
2.9%
1/35
|
|
Ear and labyrinth disorders
Motion sickness
|
2.9%
1/35
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.9%
1/35
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.9%
1/35
|
|
General disorders
Non-cardiac chest pain
|
2.9%
1/35
|
|
Cardiac disorders
Palpitations
|
2.9%
1/35
|
|
Nervous system disorders
Paraesthesia
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.9%
1/35
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/35
|
|
General disorders
Pyrexia
|
2.9%
1/35
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.9%
1/35
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
2.9%
1/35
|
|
Skin and subcutaneous tissue disorders
Tenosynovitis
|
2.9%
1/35
|
|
Nervous system disorders
Tension headache
|
2.9%
1/35
|
|
General disorders
Thirst
|
2.9%
1/35
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/35
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory tract inflammation
|
2.9%
1/35
|
|
Injury, poisoning and procedural complications
Vertebral injury
|
2.9%
1/35
|
|
Injury, poisoning and procedural complications
Wound
|
2.9%
1/35
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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 centers of the multi-center 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