Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164 - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Parkinson Disease Parkinson's Disease
Intervention:	Drug: Ropinirole XL (formerly CR)

Participant Flow

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
Study 101468/196 (this study; NCT#00650104) was an open-label, ropinirole XL (2-24 mg/day), continuation study for participants with Parkinson's Disease who previously completed Studies 167 or 164. Treatment was originally designed to continue for 3 years, but it was extended until ropinirole XL became commercially available in each study country.

Reporting Groups

	Description
Ropinirole XL	Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.

Description

Ropinirole XL

Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.

Participant Flow: Overall Study

	Ropinirole XL
STARTED	83
COMPLETED	42
NOT COMPLETED	41
Adverse Event	17
Death	2
Withdrawal by Subject	11
Physician Decision	7
Lost to Follow-up	1
Non-compliance	2
Sponsor Terminated Dosing	1

Baseline Characteristics

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Reporting Groups

	Description
Ropinirole XL	Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.

Description

Ropinirole XL

Up-titration: some participants from Study 167 started at 2 milligrams (mg) ropinirole XL once daily. Then, depending on the response/tolerance of each participant, the dose was increased in 1 mg weekly increments to 4 mg, then 2 mg weekly increments up to 12 mg, and in either 2 mg or 4 mg weekly increments up to 24 mg to the clinical optimum dose. Other Study 167 participants were increased in 2 mg weekly increments up to 8 mg and then 4 mg weekly increments up to 24 mg. Study 164 particiapnts who were on an optimal dose of ropinirole XL could go straight into the long-term treatment period, and those who were receiving ropinirole IR could be switched to the corresponding XL dose. Long-term treatment: participants received study medication until market availability of ropinirole XL. After market availability, participants would undergo a 1-week down-titration period; after protocol amendment #4 approval, participants could switch directly to the market-available dose.

Baseline Measures

	Ropinirole XL
Number of Participants [units: participants]	83
Age [units: years] Mean ± Standard Deviation	65.1 ± 9.85
Gender [units: participants]
Female	37
Male	46
Race/Ethnicity, Customized [units: participants]
Caucasian	74
Hispanic	6
Black	1
Asian	1
Other	1
Weight ^[1] [units: kilograms (kg)] Mean ± Standard Deviation	79.24 ± 16.8

[1]	Weight was captured during collection of demography data at baseline.

Outcome Measures

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1. Primary:

Unified Parkinson’s Disease (PD) Rating Scale (UPDRS) Total Activities of Daily Living Scores (Intent-to-Treat Population) [ Time Frame: Screening; Week 4; Months 3, 9, 15, 21, 27, 33, 39, 45, 51, 57, 63, 69, 75, and 78 ]

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2. Primary:

Number of Participants With the Indicated Number of Adverse Events (AEs) [ Time Frame: Every study visit from baseline to market availability (Month 78) ]

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3. Secondary:

Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Score (Responder Population) [ Time Frame: Screening; Months 3, 9, 15, 27, and 78 ]

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4. Secondary:

Unified Parkinson’s Disease Rating Scale (UPDRS) Total Activities of Daily Living Scores (Maintained Responder Population) [ Time Frame: Screening; Months 3, 9, 15, 27, and 78 ]

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5. Secondary:

Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (ITT Population) [ Time Frame: Screening and Month 78 ]

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6. Secondary:

Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Reponder Population) [ Time Frame: Screening and Month 78 ]

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7. Secondary:

Unified Parkinson’s Disease Rating Scale (UPDRS) Motor Examination Score (Maintained Responder Population) [ Time Frame: Screening and Month 78 ]

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8. Secondary:

Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (ITT Population) [ Time Frame: Week 2, Month 12, Month 78 ]

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9. Secondary:

Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Responder Population) [ Time Frame: Week 2, Month 12, Month 78 ]

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10. Secondary:

Number of Participants With the Indicated Responses for CGI Global Impression (CGI-I) (Maintained Responder Population) [ Time Frame: Week 2, Month 12, Month 78 ]

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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 by GlaxoSmithKline

Publications automatically indexed to this study:

Hauser RA, Reichmann H, Lew M, Asgharian A, Makumi C, Shulman KJ. Long-term, open-label study of once-daily ropinirole prolonged release in early Parkinson's disease. Int J Neurosci. 2011 May;121(5):246-53. Epub 2011 Jan 19.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00650104 History of Changes
Other Study ID Numbers:	101468/196
Study First Received:	March 27, 2008
Results First Received:	February 24, 2010
Last Updated:	May 11, 2011
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Norway: Norwegian Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); United States: Food and Drug Administration