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

This study has been completed.

Study NCT00530790 Information provided by GlaxoSmithKline

First Received on September 14, 2007. Last Updated on April 1, 2011 History of Changes

Results First Received: February 2, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Restless Legs Syndrome
Intervention:	Drug: ropinirole controlled release (CR)-RLS

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

Participant Flow: Overall Study

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

Baseline Characteristics

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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.

Baseline Measures

	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 [ Time Frame: Weeks 1 - 12 Treatment Period ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Primary:

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

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6. Primary:

Vital Signs and Body Weight Change From Baseline [ Time Frame: 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 [ Time Frame: Baseline and after Week 12 ]

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8. Secondary:

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

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9. Secondary:

Clinical Global Impression Global Improvement (CGI-GI) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline - Week 12/EW ]

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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 precede 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:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00530790 History of Changes
Other Study ID Numbers:	107846
Study First Received:	September 14, 2007
Results First Received:	February 2, 2009
Last Updated:	April 1, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare