Long-term Study Of Ropinirole In Restless Legs Syndrome - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Restless Legs Syndrome
Interventions:	Drug: Placebo Drug: Ropinirole

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants (par.) could enter the Open-Label (OL) phase at the end of the Double-Blind (DB) phase. If a par. did not complete the DB phase due to lack of efficacy, he/she could also be considered for entry into the OL phase if the investigator considered it appropriate and the par. met the protocol-defined criteria in describing lack of efficacy.

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
Double-blind Placebo	Matching placebo tablets
Double-blind Ropinirole IR	Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
Open-label Ropinirole IR	Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day

Participant Flow for 2 periods

Period 1: 26-Week Double-Blind Treatment Phase

	Double-blind Placebo	Double-blind Ropinirole IR
STARTED	207 ^[1]	197
COMPLETED	88	98
NOT COMPLETED	119	99
Did not complete phase; reason unknown	119	99

[1]	Numbers of participants in the "Participant Flow" section are based on the Safety Population.

Period 2: 40-Week Open-Label Treatment Phase

	Double-blind Placebo	Double-blind Ropinirole IR	Open-label Ropinirole IR
STARTED	0	0	269 ^[1]
COMPLETED	0	0	233
NOT COMPLETED	0	0	36
Adverse Event	0	0	20
Lost to Follow-up	0	0	1
Protocol Violation	0	0	2
Lack of Efficacy	0	0	9
Captured as Other	0	0	4

[1]	148 and 121 par. randomized to DB placebo and ropinirole IR, respectively, entered the OL phase.

Baseline Characteristics

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Reporting Groups

	Description
Double-Blind Placebo	Matching placebo tablets
Double-Blind Ropinirole IR	Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day

Baseline Measures

	Double-Blind Placebo	Double-Blind Ropinirole IR	Total
Number of Participants [units: participants]	207	197	404
Age ^[1] [units: years] Mean ± Standard Deviation	55.9 ± 11.53	56.5 ± 11.97	56.2 ± 11.73
Gender ^[1] [units: participants]
Female	132	124	256
Male	75	73	148
Race/Ethnicity, Customized ^[1] [units: participants]
White	204	197	401
Asian	2	0	2
Hawaiian or other Pacific Islander	1	0	1

[1]	The Safety Population, comprised of all participants who received at least one dose of study medication, was used for all demographic characteristics.

Outcome Measures

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1. Primary:

Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26 [ Time Frame: Baseline and Weeks 12 and 26 ]

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2. Primary:

Number of Participants With Clinically Meaningful Augmentation and Early Morning Rebound (EMR) Cases [ Time Frame: During 15-month study duration at scheduled (Weeks 16, 20, 26, or early withdrawal for DB phase; Weeks 39, 47, 55, 63, 67, or early withdrawal for the OL phase) and unscheduled (26-week DB phase and 40-week OL phase) visits ]

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3. Secondary:

Mean Change From Baseline in the International RLS (IRLS) Rating Scale Total Score at Weeks 1, 4, 8, 16, and 20 [ Time Frame: Baseline and Weeks 1, 4, 8, 16, and 20 ]

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4. Secondary:

Change From Baseline in the Domains of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale at Weeks 12 and 26 [ Time Frame: Baseline and Weeks 12 and 26 ]

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5. Secondary:

Change From Baseline in Sleep Quantity, a Domain of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale, at Weeks 12 and 26 [ Time Frame: Baseline and Weeks 12 and 26 ]

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6. Secondary:

Change From Baseline in the Johns Hopkins RLS Quality of Life (RLS QoL) Questionnaire Overall Life Impact Score at Weeks 12 and 26 [ Time Frame: Baseline and Weeks 12 and 26 ]

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7. Secondary:

Change From Baseline in the Domains of the MOS 36-item Short Form Health Survey (SF-36) at Weeks 12 and 26 [ Time Frame: Baseline and Weeks 12 and 26 ]

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8. Secondary:

Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 1, 12 and 26 [ Time Frame: Weeks 1, 12 and 26 ]

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9. Secondary:

Number of Participants Withdrawing Due to Lack of Efficacy During the First 26 Weeks of the Study [ Time Frame: Baseline to Week 26 ]

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10. Secondary:

Number of Participants Rated as Normal or Borderline Ill on the CGI Severity of Illness (CGI-S) Scale at Week 26 [ Time Frame: Week 26 ]

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11. Secondary:

Median Time to First CGI-I Response of Much/Very Much Improved During the Double-blind Phase [ Time Frame: Baseline to Week 26 ]

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12. Secondary:

Number of Participants With a Score of Much/Very Much Improved on the CGI-I Scale at Week 67 [ Time Frame: Week 67 ]

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13. Secondary:

Mean Change From Baseline in the IRLS Rating Scale Total Score at Week 67 [ Time Frame: Baseline and Week 67 ]

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14. Post-Hoc:

Post-hoc Analysis of Mean Change From Baseline in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 12 and Week 26, Exploring the Impact of Center Group on Treatment Effect [ Time Frame: Baseline and Weeks 12 and 26 ]

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15. Post-Hoc:

Post-hoc Analysis of Percentage of Participants With a Score of Much/Very Much Improved on the Clinical Global Impression-Global Improvement (CGI-I) Scale at Weeks 12 and 26, Exploring the Impact of Center Group on Treatment Effect [ Time Frame: Weeks 12 and 26 ]

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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 a 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:	NCT00329602 History of Changes
Other Study ID Numbers:	ROR104836
Study First Received:	May 23, 2006
Results First Received:	September 10, 2009
Last Updated:	March 24, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices