Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)

This study has been terminated.

(Because GSK concluded that it was impossible to recruit sufficient participants within a reasonable timeframe.)

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00996944

First received: October 8, 2009

Last updated: October 13, 2011

Last verified: October 2011

History of Changes

Results First Received: February 10, 2011

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

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
This study was prematurely terminated after 5 months had passed since its initiation, because GlaxoSmithKline (GSK) concluded that it was impossible to recruit sufficient participants within a reasonable timeframe. In this study, no participants had completed. The maximum duration was 24 weeks plus follow-up (up to Week 64).

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 IR-Ropinirole IR	Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Placebo-Ropinirole IR	Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.

Description

Ropinirole IR-Ropinirole IR

Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.

Placebo-Ropinirole IR

Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.

Participant Flow for 2 periods

Period 1: Double-blind Treatment Period

	Ropinirole IR-Ropinirole IR	Placebo-Ropinirole IR
STARTED	22	12
COMPLETED	12	5
NOT COMPLETED	10	7
Adverse Event	2	1
Protocol Violation	1	0
Study Closed/Terminated	6	5
Withdrawal by Subject	1	1

Period 2: Long-term Treatment Period

	Ropinirole IR-Ropinirole IR	Placebo-Ropinirole IR
STARTED	12	5
COMPLETED	0	0
NOT COMPLETED	12	5
Study Closed/Terminated	12	5

Baseline Characteristics

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Reporting Groups

	Description
Ropinirole IR-Ropinirole IR	Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
Placebo-Ropinirole IR	Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
Total	Total of all reporting groups

Baseline Measures

	Ropinirole IR-Ropinirole IR	Placebo-Ropinirole IR	Total
Number of Participants [units: participants]	22	12	34
Age [units: Years] Mean ± Standard Deviation	53.5 ± 11.39	53.8 ± 10.90	53.6 ± 11.06
Gender [units: Participants]
Female	3	4	7
Male	19	8	27
Race/Ethnicity, Customized [units: participants]
Asian - Japanese Heritage	22	12	34
Not Asian - Japanese Heritage	0	0	0
Age at Onset of Restless Legs Syndrome [units: years] Mean ± Standard Deviation	48.9 ± 11.24	49.4 ± 10.12	49.1 ± 10.71
Duration of Dialysis [units: years] Mean ± Standard Deviation	7.41 ± 5.537	6.08 ± 5.274	6.94 ± 5.403

Outcome Measures

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1. Primary:

International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12 [ Time Frame: Week 0 and Week 12 ]

Show Outcome Measure 1

2. Primary:

IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) [ Time Frame: DBT WD (up to Week 12) ]

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3. Secondary:

IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD) [ Time Frame: LONG WD (up to Week 64) ]

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4. Secondary:

Number of Participants With the Indicated Clinical Global Impression–Improvement (CGI-I) Scores at Week 12 [ Time Frame: Week 12 ]

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5. Secondary:

Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) [ Time Frame: DBT WD (up to Week 12) ]

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6. Secondary:

Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD) [ Time Frame: LONG WD (up to Week 64) ]

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7. Secondary:

Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12 [ Time Frame: Week 0 and Week 12 ]

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8. Secondary:

Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) [ Time Frame: DBT WD (up to Week 12) ]

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9. Secondary:

Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD) [ Time Frame: LONG WD (up to Week 64) ]

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10. Secondary:

The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12 [ Time Frame: Week 0 and Week 12 ]

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11. Secondary:

The PSQI Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) [ Time Frame: DBT WD (up to Week 12) ]

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12. Secondary:

The PSQI Total Score for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD) [ Time Frame: LONG WD (up to Week 64) ]

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13. Secondary:

Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12 [ Time Frame: Week 0 and Week 12 ]

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14. Secondary:

Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD) [ Time Frame: LONG WD (up to Week 64) ]

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15. Secondary:

Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) [ Time Frame: DBT WD (up to Week 12) ]

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16. Secondary:

Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12 [ Time Frame: Week 0 and Week 12 ]

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17. Secondary:

Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) [ Time Frame: DBT WD (up to Week 12) ]

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18. Secondary:

Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD) [ Time Frame: LONG WD (up to Week 64) ]

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19. Secondary:

Drug Clearance Rate On-Dialysis and Off-Dialysis During the Maintenance Dose Treatment Phase (in the Long-term Treatment Period) [ Time Frame: Week 12 through Week 64 ]

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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
No text entered.

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:	NCT00996944 History of Changes
Other Study ID Numbers:	113079
Study First Received:	October 8, 2009
Results First Received:	February 10, 2011
Last Updated:	October 13, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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