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

	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

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1. Primary:

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

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Primary:

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

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6. Primary:

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

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7. Secondary:

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

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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 ]

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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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 ]

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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 preceed the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

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