An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease

This study has been completed.

Study NCT00632736 Information provided by GlaxoSmithKline

First Received on March 4, 2008. Last Updated on March 17, 2011 History of Changes

Results First Received: December 2, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety 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

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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
Study 101468/248 (this study, NCT00632736) was an open-label extension study with ropinirole extended release (XL) for subjects from studies 101468/165, 101468/168, and 101468/169 (NCT00381472).

Reporting Groups

	Description
Ropinirole XL	Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.

Participant Flow: Overall Study

	Ropinirole XL
STARTED	419
COMPLETED	151
NOT COMPLETED	268
Adverse Event	104
Lost to Follow-up	15
Protocol Violation	14
Withdrawal by Subject	99
Lack of Efficacy	5
Sponsor terminated study	5
Non-compliance	10
Unknown	16

Baseline Characteristics

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Reporting Groups

	Description
Ropinirole XL	Ropinirole extended release (XL) doses of 8 milligrams (mg)/day, 12 mg/day, 16 mg/day, 20 mg/day, or 24 mg/day taken once daily. As this was an extension study, the dose was a continuation of the dose the participant would have been receiving in the parent study.

Baseline Measures

	Ropinirole XL
Number of Participants [units: participants]	419
Age [units: Years] Mean ± Standard Deviation	64.3 ± 9.81
Gender [units: Participants]
Female	160
Male	259
Race/Ethnicity, Customized [units: participants]
White/Caucasian	409
American Hispanic	5
Black	2
Arabic/North African	0
East & South East Asian	2
South Asian	0
Unknown	1
Body Mass Index (BMI) ^[1] [units: kilograms per square meters (kg/m^2)] Mean ± Standard Deviation	26.5 ± 4.48

[1]	BMI is a measure of body fat based on height and weight and is calculated as weight (kilograms) divided by height (meters squared).

Outcome Measures

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1. Primary:

Number of Participants With the Indicated Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 13 February 2004 through 31 March 2010 ]

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2. Secondary:

Number of Participants With the Indicated Response to the Patient Preference Question at Week 4 and Week 26 [ Time Frame: Week 4 and Week 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:	NCT00632736 History of Changes
Other Study ID Numbers:	101468/248
Study First Received:	March 4, 2008
Results First Received:	December 2, 2010
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration; Hungary: National Institute of Pharmacy; Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control