Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	Restless Legs Syndrome (RLS)
Intervention:	Drug: ropinirole controlled release (CR)-RLS

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

	Ropinirole CR-RLS
STARTED	35
COMPLETED	30
NOT COMPLETED	5
Adverse Event	2
Withdrawal by Subject	2
Physician Decision	1

	Ropinirole CR-RLS
Number of Participants [units: participants]	35
Age [units: years] Mean ± Standard Deviation	48.2 ± 14.7
Gender [units: Number of participants]
Female	23
Male	12
Region of Enrollment [units: Number of participants]
Japan	35

Outcome Measures

1. Primary:

Drug Related Adverse Events-On-Therapy [ Weeks 1 - 12 Treatment Period ]

Measure Type	Primary
Measure Title	Drug Related Adverse Events-On-Therapy
Measure Description	No text entered.
Time Frame	Weeks 1 - 12 Treatment Period
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population consisting of the subjects who took at least one dose of the study medication.

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Drug Related Adverse Events-On-Therapy [units: Number of Events]
Subjects with any Adverse Events	29
Nausea	14
Somnolence	5
Vomiting	5
Hypersomnia	3
Diarrhea	2
Dizziness	2
Dyspepsia	2
Fatigue	2
Stomach discomfort	2
Abdominal pain	1
Anemia	1
Insomnia	1
Irritability	1
Malaise	1
Middle Insomnia	1
Motion Sickness	1
Palpitations	1
Thirst	1

No statistical analysis provided for Drug Related Adverse Events-On-Therapy

2. Primary:

Haematology Clinical Lab Values Change From Baseline [ Baseline - Week 13 (Follow-up) ]

Measure Type	Primary
Measure Title	Haematology Clinical Lab Values Change From Baseline
Measure Description	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.
Time Frame	Baseline - Week 13 (Follow-up)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Haematology Clinical Lab Values Change From Baseline [units: Varied Standard Units of Measure] Mean ± Standard Deviation
Hemoglobin (G/L) - week 4	-1.2 ± 6.97
Hemoglobin (G/L) - week 8	-2.7 ± 8.79
Hemoglobin (G/L) - week 12	-1.0 ± 4.84
Hemoglobin (G/L) - week 12/EW	-0.8 ± 4.69
Hemoglobin (G/L)- week 13	-2.2 ± 7.30
Hematocrit (SI) - week 4	-0.0033 ± 0.01972
Hematocrit (SI) - week 8	-0.0074 ± 0.02470
Hematocrit (SI) - week 12	-0.0021 ± 0.01174
Hematocrit (SI) - week 12/EW	-0.0016 ± 0.01148
Hematocrit (SI) - week 13	-0.0063 ± 0.01929
Platelet Count (GI/L) - week 4	14.5 ± 26.86
Platelet Count (GI/L) - week 8	11.7 ± 27.92
Platelet Count (GI/L) - week 12	8.5 ± 22.79
Platelet Count (GI/L) - week 12/EW	8.8 ± 21.74
Platelet Count (GI/L) - week 13	10.7 ± 41.48
Red Blood Cell Count (TI/L) - week 4	-0.043 ± 0.2139
Red Blood Cell Count (TI/L) - week 8	-0.084 ± 0.2701
Red Blood Cell Count (TI/L) - week 12	-0.015 ± 0.1469
Red Blood Cell Count (TI/L) - week 12/EW	-0.011 ± 0.1411
Red Blood Cell Count (TI/L) - week 13	-0.050 ± 0.2140
White Blood Cell Count (GI/L) - week 4	-0.191 ± 1.1655
White Blood Cell Count (GI/L) - week 8	-0.268 ± 1.8694
White Blood Cell Count (GI/L) - week 12	-0.577 ± 1.4972
White Blood Cell Count (GI/L) - week 12/EW	-0.516 ± 1.4407
White Blood Cell Count (GI/L) - week 13	-0.624 ± 1.4914

No statistical analysis provided for Haematology Clinical Lab Values Change From Baseline

3. Primary:

Blood Chemistry Clinical Lab Values Change From Baseline [ Baseline - Week 13 (Follow-up) ]

Measure Type	Primary
Measure Title	Blood Chemistry Clinical Lab Values Change From Baseline
Measure Description	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
Time Frame	Baseline - Week 13 (Follow-up)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Blood Chemistry Clinical Lab Values Change From Baseline [units: Varied Standard Units of Measure] Mean ± Standard Deviation
Albumin (G/L) - week 4	-1.0 ± 2.35
Albumin (G/L) - week 8	-1.4 ± 2.64
Albumin (G/L) - week 12	-0.7 ± 2.34
Albumin (G/L) - week 12/EW	-0.6 ± 2.28
Albumin (G/L) - week 13	-1.3 ± 2.33
Alkaline Phosphatase (IU/L) - week 4	5.2 ± 30.53
Alkaline Phosphatase (IU/L) - week 8	4.2 ± 26.94
Alkaline Phosphatase (IU/L) - week 12	13.2 ± 29.35
Alkaline Phosphatase (IU/L) - week 12/EW	13.4 ± 28.52
Alkaline Phosphatase (IU/L) - week 13	16.0 ± 36.45
Alanine Amino Transferase (IU/L) - week 4	-0.3 ± 3.80
Alanine Amino Transferase (IU/L) - week 8	-0.7 ± 5.08
Alanine Amino Transferase (IU/L) - week 12	1.7 ± 4.66
Alanine Amino Transferase - week 12/EW	1.8 ± 4.56
Alanine Amino Transferase - week 13	1.4 ± 6.36
Aspartate Amino Transferase(IU/L) - week 4	0.4 ± 4.55
Aspartate Amino Transferase (IU/L) - week 8	-0.2 ± 4.07
Aspartate Amino Transferase (IU/L) - week 12	1.3 ± 4.57
Aspartate Amino Transferase (IU/L) - week 12/EW	1.5 ± 4.51
Aspartate Amino Transferase (IU/L) - week 13	0.6 ± 4.35
Total Bilirubin (UMOL/L) - week 4	0.147 ± 3.1686
Total Bilirubin (UMOL/L) - week 8	-0.588 ± 2.5180
Total Bilirubin (UMOL/L) - week 12	0.513 ± 3.4244
Total Bilirubin (UMOL/L) - week 12/EW	0.311 ± 3.3513
Total Bilirubin (UMOL/L) - week 13	-1.173 ± 3.7959
Blood Urea Nitrogen (MMOL/L) - week 4	-0.14382 ± 1.079245
Blood Urea Nitrogen (MMOL/L) - week 8	-0.06024 ± 0.862798
Blood Urea Nitrogen (MMOL/L) - week 12	0.25704 ± 1.076664
Blood Urea Nitrogen (MMOL/L) - week 12/EW	0.30399 ± 1.043047
Blood Urea Nitrogen (MMOL/L) - week 13	0.32334 ± 0.974457
Cholesterol (MMOL/L) - week 4	-0.093835 ± 0.5322345
Cholesterol (MMOL/L) - week 8	-0.190717 ± 0.4337538
Cholesterol (MMOL/L) - week 12	0.151712 ± 0.5674075
Cholesterol (MMOL/L) - week 12/EW	0.146540 ± 0.5494743
Cholesterol - week 13	-0.107873 ± 0.5638668
Chloride(MMOL/L) - week 4	0.1 ± 1.78
Chloride (MMOL/L) - week 8	0.3 ± 2.07
Chloride (MMOL/L) - week 12	-0.3 ± 1.81
Chloride (MMOL/L) - week 12/EW	-0.2 ± 1.92
Chloride (MMOL/L) - week 13	-0.1 ± 2.30
Lactate Dehydrogenase (IU/L) - week 4	0.3 ± 22.02
Lactate Dehydrogenase (IU/L) - week 8	-1.3 ± 16.74
Lactate Dehydrogenase (IU/L) - week 12	2.0 ± 25.96
Lactate Dehydrogenase (IU/L) - week 12/EW	2.7 ± 25.06
Lactate Dehydrogenase (IU/L) - week 13	-2.2 ± 18.78
Sodium (MMOL/L) - week 4	-0.4 ± 1.37
Sodium (MMOL/L) - week 8	-0.2 ± 1.36
Sodium (MMOL/L) - week 12	0.0 ± 1.11
Sodium (MMOL/L) - week 12/EW	-0.0 ± 1.07
Sodium (MMOL/L) - week 13	-0.2 ± 1.29
Prolactin (MCG/L) - week 4	0.80 ± 7.003
Prolactin (MCG/L) - week 8	0.51 ± 7.229
Prolactin (MCG/L) - week 12	0.20 ± 6.770
Prolactin (MCG/L) - week 12/EW	0.22 ± 6.466
Prolactin (MCG/L) - week 13	1.14 ± 7.144
Total Protein (G/L) - week 4	-1.1 ± 3.73
Total Protein (G/L) - week 8	-1.7 ± 4.03
Total Protein (G/L) - week 12	-0.8 ± 3.32
Total Protein (G/L) - week 12/EW	-0.8 ± 3.20
Total Protein (G/L) - week 13	-2.2 ± 3.45
Creatine Phosphokinase (IU/L) - week 4	72.3 ± 533.72
Creatine Phosphokinase (IU/L) - week 8	-15.8 ± 100.86
Creatine Phosphokinase (IU/L) - week 12	-0.6 ± 115.92
Creatine Phosphokinase (IU/L) - week 12/EW	-0.2 ± 110.40
Creatine Phosphokinase (IU/L) - week 13	-1.9 ± 124.63
Creatinine (UMOL/L) - week 4	1.3134 ± 4.76710
Creatinine (UMOL/L) - week 8	0.5801 ± 7.23972
Creatinine (UMOL/L) - week 12	1.0019 ± 4.73343
Creatinine (UMOL/L) - week 12/EW	1.0447 ± 4.60113
Creatinine (UMOL/L) - week 13	1.6417 ± 4.96904
Gamma Glutamyl Transferase (IU/L) - week 4	1.5 ± 17.56
Gamma Glutamyl Transferase (IU/L) - week 8	-1.4 ± 11.68
Gamma Glutamyl Transferase (IU/L) - week 12	1.9 ± 14.56
Gamma Glutamyl Transferase (IU/L) - week 12/EW	2.6 ± 14.26
Gamma Glutamyl Tranferase (IU/L) - week 13	0.1 ± 10.10
Potassium (MMOL/L) - week 4	0.07 ± 0.280
Potassium (MMOL/L) - week 8	0.05 ± 0.363
Potassium (MMOL/L) - week 12	0.09 ± 0.305
Potassium (MMOL/L) - week 12/EW	0.10 ± 0.293
Potassium (MMOL/L) - week 13	0.06 ± 0.308

No statistical analysis provided for Blood Chemistry Clinical Lab Values Change From Baseline

4. Primary:

Urinalysis Clinical Lab Values [ Baseline - Week 13 (Follow-up) ]

Measure Type	Primary
Measure Title	Urinalysis Clinical Lab Values
Measure Description	Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.
Time Frame	Baseline - Week 13 (Follow-up)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Urinalysis Clinical Lab Values [units: Participants]
Urine Urobilinogen - Baseline: Neg Value	0
Urine Urobilinogen - Baseline: Trace	35
Urine Urobilinogen - Baseline: +1	0
Urine Urobilinogen - Baseline: +2	0
Urine Urobilinogen - Baseline: +3	0
Urine Urobilinogen - week 4: Neg Value	0
Urine Urobilinogen - week 4: Trace	35
Urine Urobilinogen - week 4: +1	0
Urine Urobilinogen - week 4: +2	0
Urine Urobilinogen - week 4: +3	0
Urine Urobilinogen - week 8: Neg Value	0
Urine Urobilinogen - week 8: Trace	32
Urine Urobilinogen - week 8: +1	0
Urine Urobilinogen - week 8: +2	0
Urine Urobilinogen - week 8: +3	0
Urine Urobilinogen - week 12: Neg Value	0
Urine Urobilinogen - week 12: Trace	30
Urine Urobilinogen - week 12: +1	0
Urine Urobilinogen - week 12: +2	0
Urine Urobilinogen - week 12: +3	0
Urine Urobilinogen - week 12/EW: Neg Value	0
Urine Urobilinogen - week 12/EW: Trace	33
Urine Urobilinogen - week 12/EW: +1	0
Urine Urobilinogen - week 12/EW: +2	0
Urine Urobilinogen - week 12/EW: +3	0
Urine Urobilinogen - week 13: Neg Value	0
Urine Urobilinogen - week 13: Trace	35
Urine Urobilinogen - week 13: +1	0
Urine Urobilinogen - week 13: +2	0
Urine Urobilinogen - week 13: +3	0
Urine Protein - Baseline: Neg Value	34
Urine Protein - Baseline: Trace	1
Urine Protein - Baseline: +1	0
Urine Protein - Baseline: +2	0
Urine Protein - Baseline: +3	0
Urine Protein - Week 4: Neg Value	35
Urine Protein - Week 4: Trace	0
Urine Protein - Week 4: +1	0
Urine Protein - Week 4: +2	0
Urine Protein - Week 4: +3	0
Urine Protein - Week 8: Neg Value	31
Urine Protein - Week 8: Trace	1
Urine Protein - Week 8: +1	0
Urine Protein - Week 8: +2	0
Urine Protein - Week 8: +3	0
Urine Protein - Week 12: Neg Value	30
Urine Protein - Week 12: Trace	0
Urine Protein - Week 12: +1	0
Urine Protein - Week 12: +2	0
Urine Protein - Week 12: +3	0
Urine Protein - Week 12/EW: Neg Value	33
Urine Protein - Week 12/EW: Trace	0
Urine Protein - Week 12/EW: +1	0
Urine Protein - Week 12/EW: +2	0
Urine Protein - Week 12/EW: +3	0
Urine Protein - Week 13: Neg Value	35
Urine Protein - Week 13: Trace	0
Urine Protein - Week 13: +1	0
Urine Protein - Week 13: +2	0
Urine Protein - Week 13: +3	0
Urine Occult Blood - Baseline: Neg Value	27
Urine Occult Blood - Baseline: Trace	5
Urine Occult Blood - Baseline: +1	3
Urine Occult Blood - Baseline: +2	0
Urine Occult Blood - Baseline: +3	0
Urine Occult Blood - Week 4: Neg Value	20
Urine Occult Blood - Week 4: Trace	7
Urine Occult Blood - Week 4: +1	6
Urine Occult Blood - Week 4: +2	2
Urine Occult Blood - Week 4: +3	0
Urine Occult Blood - Week 8: Neg Value	25
Urine Occult Blood - Week 8: Trace	3
Urine Occult Blood - Week 8: +1	3
Urine Occult Blood - Week 8: +2	0
Urine Occult Blood - Week 8: +3	1
Urine Occult Blood - Week 12: Neg Value	23
Urine Occult Blood - Week 12: Trace	4
Urine Occult Blood - Week 12: +1	2
Urine Occult Blood - Week 12: +2	1
Urine Occult Blood - Week 12: +3	0
Urine Occult Blood - Week 12/EW: Neg Value	25
Urine Occult Blood - Week 12/EW: Trace	5
Urine Occult Blood - Week 12/EW: +1	2
Urine Occult Blood - Week 12/EW: +2	1
Urine Occult Blood - Week 12/EW: +3	0
Urine Occult Blood - Week 13: Neg Value	26
Urine Occult Blood - Week 13: Trace	3
Urine Occult Blood - Week 13: +1	6
Urine Occult Blood - Week 13: +2	0
Urine Occult Blood - Week 13: +3	0
Urine Glucose - Baseline: Neg Value	35
Urine Glucose - Baseline: Trace	0
Urine Glucose - Baseline: +1	0
Urine Glucose - Baseline: +2	0
Urine Glucose - Baseline: +3	0
Urine Glucose - Week 4: Neg Value	34
Urine Glucose - Week 4: Trace	0
Urine Glucose - Week 4: +1	1
Urine Glucose - Week 4: +2	0
Urine Glucose - Week 4: +3	0
Urine Glucose - Week 8: Neg Value	31
Urine Glucose - Week 8: Trace	1
Urine Glucose - Week 8: +1	0
Urine Glucose - Week 8: +2	0
Urine Glucose - Week 8: +3	0
Urine Glucose - Week 12: Neg Value	29
Urine Glucose - Week 12: Trace	1
Urine Glucose - Week 12: +1	0
Urine Glucose - Week 12: +2	0
Urine Glucose - Week 12: +3	0
Urine Glucose - Week 12/EW: Neg Value	32
Urine Glucose - Week 12/EW: Trace	1
Urine Glucose - Week 12/EW: +1	0
Urine Glucose - Week 12/EW: +2	0
Urine Glucose - Week 12/EW: +3	0
Urine Glucose - Week 13: Neg Value	35
Urine Glucose - Week 13: Trace	0
Urine Glucose - Week 13: +1	0
Urine Glucose - Week 13: +2	0
Urine Glucose - Week 13: +3	0

No statistical analysis provided for Urinalysis Clinical Lab Values

5. Primary:

12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline [ Baseline, Week 4, 8, 12, 13 (Follow-up) ]

Measure Type	Primary
Measure Title	12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
Measure Description	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.
Time Frame	Baseline, Week 4, 8, 12, 13 (Follow-up)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline [units: Participants]
Baseline: N; Baseline: N	29
Baseline: N; Baseline: ANCS	0
Baseline: N; Baseline: ACS	0
Baseline: ANCS; Baseline: N	0
Baseline: ANCS; Baseline: ANCS	5
Baseline: ANCS; Baseline: ACS	0
Baseline: ACS; Baseline: N	0
Baseline; ACS; Baseline: ANCS	0
Baseline: ACS ; Baseline: ACS	1
Baseline: N; Week 4: N	27
Baseline: N; Week 4: ANCS	1
Baseline: N; Week 4: ACS	0
Baseline: ANCS; Week 4: N	2
Baseline: ANCS; Week 4: ANCS	1
Baseline: ANCS; Week 4: ACS	1
Baseline: ACS; Week 4: N	0
Baseline: ACS; Week 4: ANCS	0
Baseline: ACS; Week 4: ACS	1
Baseline: N; Week 8: N	24
Baseline: N; Week 8: ANCS	2
Baseline: N; Week 8: ACS	0
Baseline: ANCS; Week 8: N	2
Baseline: ANCS; Week 8: ANCS	1
Baseline: ANCS; Week 8: ACS	1
Baseline: ACS; Week 8: N	0
Baseline: ACS; Week 8: ANCS	1
Baseline: ACS; Week 8: ACS	0
Baseline: N; Week 12/EW: N	27
Baseline: N; Week 12/EW: ANCS	0
Baseline: N; Week 12/EW: ACS	0
Baseline: ANCS; Week 12/EW: N	4
Baseline: ANCS; Week 12/EW: ANCS	0
Baseline: ANCS; Week 12/EW: ACS	1
Baseline: ACS; Week 12/EW: N	0
Baseline: ACS; Week 12/EW: ANCS	0
Baseline: ACS; Week 12/EW: ACS	1
Baseline: N; Week 13: N	27
Baseline: N; Week 13: ANCS	2
Baseline: N; Week 13: ACS	0
Baseline: ANCS; Week 13: N	2
Baseline: ANCS; Week 13: ANCS	2
Baseline: ANCS; Week 13: ACS	1
Baseline: ACS; Week 13: N	0
Baseline: ACS; Week 13: ANCS	0
Baseline: ACS; Week 13: ACS	1

No statistical analysis provided for 12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline

6. Primary:

Vital Signs and Body Weight Change From Baseline [ Baseline to Week 12/EW ]

Measure Type	Primary
Measure Title	Vital Signs and Body Weight Change From Baseline
Measure Description	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.
Time Frame	Baseline to Week 12/EW
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	33
Vital Signs and Body Weight Change From Baseline [units: Varied Standard Units of Measure] Mean ± Standard Deviation
Weight (Kg)	0.5 ± 1.33
Semi-Supine Systolic BP (mmHg)	2.7 ± 10.68
Semi-Supine Diastolic BP (mmHg)	2.6 ± 7.25
Semi-Supine Pulse Rate (bpm)	0.8 ± 9.11
Standing Systolic BP (mmHg)	-0.7 ± 10.86
Standing Diastolic BP (mmHg)	0.8 ± 7.64
Standing Pulse Rate (bpm)	1.1 ± 9.94
Orthostatic Systolic BP (mmHg)	-1.5 ± 8.50
Orthostatic Diastolic BP (mmHg)	4.3 ± 5.58
Orthostatic Pulse Rate (bpm)	9.2 ± 9.15

No statistical analysis provided for Vital Signs and Body Weight Change From Baseline

7. Secondary:

Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score [ Baseline and after Week 12 ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score
Measure Description	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.
Time Frame	Baseline and after Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score [units: Points on a scale] Mean ± Standard Deviation
IRLS assessment Score - week 0	25.3 ± 4.42
IRLS assessment Score - week 12	6.0 ± 7.5
Change from Baseline at week 12	-19.3 ± 7.68

No statistical analysis provided for Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score

8. Secondary:

Clinical Global Impression Scale - Severity of Illness (CGI-S) [ Baseline - Final assessment point ]

Measure Type	Secondary
Measure Title	Clinical Global Impression Scale - Severity of Illness (CGI-S)
Measure Description	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).
Time Frame	Baseline - Final assessment point
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Clinical Global Impression Scale - Severity of Illness (CGI-S) [units: Participants]
Baseline - Normal	0
Baseline - Borderline	0
Baseline - Mildly	0
Baseline - Moderately	13
Baseline - Markedly	13
Baseline - Severely	9
Week 1 - Normal	0
Week 1 - Borderline	3
Week 1 - Mildly	10
Week 1 - Moderately	16
Week 1 - Markedly	4
Week 1 - Severely	2
Week 2 - Normal	3
Week 2 - Borderline	7
Week 2 - Mildly	12
Week 2 - Moderately	10
Week 2 - Markedly	2
Week 2 - Severely	1
Week 3 - Normal	11
Week 3 - Borderline	7
Week 3 - Mildly	8
Week 3 - Moderately	7
Week 3 - Markedly	1
Week 3 - Severely	1
Week 4 - Normal	9
Week 4 - Borderline	9
Week 4 - Mildly	10
Week 4 - Moderately	5
Week 4 - Markedly	1
Week 4 - Severely	1
Week 5 - Normal	11
Week 5 - Borderline	6
Week 5 - Mildly	11
Week 5 - Moderately	4
Week 5 - Markedly	1
Week 5 - Severely	0
Week 6 - Normal	13
Week 6 - Borderline	4
Week 6 - Mildly	11
Week 6 - Moderately	4
Week 6 - Markedly	1
Week 6 - Severely	0
Week 8 - Normal	10
Week 8 - Borderline	10
Week 8 - Mildly	8
Week 8 - Moderately	3
Week 8 - Markedly	1
Week 8 - Severely	0
Week 10 - Normal	15
Week 10 - Borderline	5
Week 10 - Mildly	8
Week 10 - Moderately	1
Week 10 - Markedly	1
Week 10 - Severely	0
Week 12 - Normal	16
Week 12 - Borderline	3
Week 12 - Mildly	10
Week 12 - Moderately	0
Week 12 - Markedly	1
Week 12 - Severely	0
Final assessment point - Normal	17
Final assessment point - Borderline	3
Final assessment point - Mildly	12
Final assessment point - Moderately	1
Final assessment point - Markedly	1
Final assessment point - Severely	1

No statistical analysis provided for Clinical Global Impression Scale - Severity of Illness (CGI-S)

9. Secondary:

Clinical Global Impression Global Improvement (CGI-GI) [ Baseline - Final assessment point ]

Measure Type	Secondary
Measure Title	Clinical Global Impression Global Improvement (CGI-GI)
Measure Description	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).
Time Frame	Baseline - Final assessment point
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Clinical Global Impression Global Improvement (CGI-GI) [units: Participants]
Week 1 - Very Much Improved	4
Week 1 - Much Improved	12
Week 1 - Minimally Improved	13
Week 1 - No Change	6
Week 2 - Very Much Improved	15
Week 2 - Much Improved	9
Week 2 - Minimally Improved	9
Week 2 - No Change	2
Week 3 - Very Much Improved	21
Week 3 - Much Improved	7
Week 3 - Minimally Improved	6
Week 3 - No Change	1
Week 4 - Very Much Improved	21
Week 4 - Much Improved	7
Week 4 - Minimally Improved	6
Week 4 - No Change	1
Week 5 - Very Much Improved	21
Week 5 - Much Improved	6
Week 5 - Minimally Improved	6
Week 5 - No Change	0
Week 6 - Very Much Improved	22
Week 6 - Much Improved	7
Week 6 - Minimally Improved	4
Week 6 - No Change	0
Week 8 - Very Much Improved	24
Week 8 - Much Improved	6
Week 8 - Minimally Improved	2
Week 8 - No Change	0
Week 10 - Very Much Improved	22
Week 10 - Much Improved	6
Week 10 - Minimally Improved	2
Week 10 - No Change	0
Week 12 - Very Much Improved	25
Week 12 - Much Improved	4
Week 12 - Minimally Improved	0
Week 12 - No Change	1
Final assessment point - Very Much Improved	27
Final assessment point - Much Improved	5
Final assessment point - Minimally Improved	1
Final assessment point - No Change	2

No statistical analysis provided for Clinical Global Impression Global Improvement (CGI-GI)

10. Secondary:

Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score [ Baseline - Week 12/EW ]

Measure Type	Secondary
Measure Title	Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score
Measure Description	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.
Time Frame	Baseline - Week 12/EW
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set(FAS)

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score [units: Points on a scale] Mean ± Standard Deviation
PSQI Total Score at Baseline	9.4 ± 3.20
PSQI Total Score at Week 12/EW	5.4 ± 2.89
Change from Baseline at Week 12/EW	-4.2 ± 3.94

No statistical analysis provided for Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score

11. Secondary:

Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains [ Baseline - Week 12/EW ]

Measure Type	Secondary
Measure Title	Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Measure Description	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.
Time Frame	Baseline - Week 12/EW
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set(FAS)

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains [units: Points on a scale] Mean ± Standard Deviation
Sleep Quality - Baseline	2.0 ± 0.62
Sleep Quality - Week 12/EW	1.2 ± 0.77
Sleep Quality - Change from Baseline	-0.9 ± 0.78
Duration getting to sleep - Baseline	2.0 ± 1.04
Duration getting to sleep - Week 12/EW	1.0 ± 0.88
Duration getting to sleep - Change from Baseline	-1.1 ± 1.09
Sleep Duration - Baseline	1.9 ± 0.77
Sleep Duration - Week 12/EW	1.5 ± 0.79
Sleep Duration - Change from Baseline	-0.4 ± 0.74
Sleep Adequacy - Baseline	0.9 ± 1.11
Sleep Adequacy - Week 12/EW	0.4 ± 0.70
Sleep Adequacy - Change from Baseline	-0.6 ± 1.19
Sleep Disturbance - Baseline	1.2 ± 0.43
Sleep Disturbance - Week 12/EW	0.9 ± 0.55
Sleep Disturbance - Change from Baseline	-0.3 ± 0.60
Use of Sleeping pill - Baseline	0.4 ± 1.01
Use of Sleeping pill - Week 12/EW	0.0 ± 0.00
Use of Sleeping pill - Change from Baseline	-0.4 ± 1.03
Somnolence - Baseline	1.0 ± 0.92
Somnolence - Week 12/EW	0.5 ± 0.62
Somnolence - Change from Baseline	-0.5 ± 0.97

No statistical analysis provided for Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains

12. Secondary:

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 [ Baseline and Week 12/EW ]

Measure Type	Secondary
Measure Title	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
Measure Description	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
Time Frame	Baseline and Week 12/EW
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set(FAS)

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	33
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 [units: Points on a scale] Mean ± Standard Deviation
RLSQOL Overall Life Impact Score - Baseline	65.29 ± 14.499
RLSQOL Overall Life Impact Score - Week 12	89.09 ± 13.431
Change from Baseline	23.94 ± 16.759

No statistical analysis provided for 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

13. Secondary:

Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS) [ Baseline and Week 12/EW ]

Measure Type	Secondary
Measure Title	Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)
Measure Description	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
Time Frame	Baseline and Week 12/EW
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	33
Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS) [units: Points on a scale] Mean ± Standard Deviation
POMS - Baseline	59.2 ± 21.59
POMS - Week 12/EW	48.0 ± 18.69
Change from Baseline	-10.4 ± 14.46

No statistical analysis provided for Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)

14. Secondary:

Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS) [ Baseline - Week 12/EW ]

Measure Type	Secondary
Measure Title	Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)
Measure Description	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.
Time Frame	Baseline - Week 12/EW
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS) [units: Points on a scale] Mean ± Standard Deviation
Anxiety-HADS Anxiety Population - Baseline	9.3 ± 1.50
Anxiety-HADS Anxiety Population - Week 12/EW	7.7 ± 2.39
Change from Baseline for Anxiety Population	-1.8 ± 2.58
Depression-HADS Depression Population -Baseline	9.7 ± 1.42
Depression-HADS Depression Population-Week 12/EW	9.5 ± 1.57
Change from Baseline for Depression Population	-0.1 ± 1.77

No statistical analysis provided for Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)

15. Secondary:

Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole. [ Weeks 1-12 ]

Measure Type	Secondary
Measure Title	Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.
Measure Description	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.
Time Frame	Weeks 1-12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole. [units: picograms/mL] Mean ± Standard Deviation
35 subjects who received 0.5 mg of Study drug	310.01 ± 188.460
27subjects who received 1 mg of Study drug	500.97 ± 293.344
11 subjects who received 2 mg of Study drug	968.36 ± 696.327
2 subjects who received 3 mg of Study drug	1294.55 ± 442.861
2 subjects who received 4 mg of Study drug	1198.10 ± 362.463

No statistical analysis provided for Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.

16. Secondary:

Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole. [ Weeks 1 -12 ]

Measure Type	Secondary
Measure Title	Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.
Measure Description	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.
Time Frame	Weeks 1 -12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole. [units: picograms/mL] Mean ± Standard Deviation
35 subjects who received 0.5 mg of Study drug	324.65 ± 134.576
27 subjects who received 1 mg of Study drug	615.91 ± 259.145
11 subjects who received 2 mg of Study drug	1320.31 ± 523.622
2 subjects who received 3 mg of Study drug	1666.65 ± 325.764
2 subjects who received 4 mg of Study drug	2541.95 ± 198.202

No statistical analysis provided for Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.

17. Secondary:

Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole. [ Weeks 1-12 ]

Measure Type	Secondary
Measure Title	Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.
Measure Description	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.
Time Frame	Weeks 1-12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PK Population

Reporting Groups

	Description
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.

Measured Values

	Ropinirole CR-RLS
Number of Participants Analyzed [units: participants]	35
Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole. [units: picograms/mL] Mean ± Standard Deviation
2 subjects who received 0.5 mg of Study drug	22.45 ± 3.465
11 subjects who received 1 mg of Study drug	30.37 ± 10.227
11 subjects who received 2 mg of Study drug	42.75 ± 17.286
2 subjects who received 3 mg of Study drug	46.80 ± 8.202
2 subjects who received 4 mg of Study drug	72.05 ± 2.051

No statistical analysis provided for Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107846, NCT00530790
Study First Received:	September 14, 2007
Results First Received:	February 2, 2009
Last Updated:	September 17, 2009
ClinicalTrials.gov Identifier:	NCT00530790 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare