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COMPLETEDPHASE3

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

An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169

NCT00632736•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A subject will be eligible for inclusion in this study only if all of the following criteria apply:
•Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down titration at the end of treatment/early withdrawal).
•Subjects must not have a break in medication between completing the feeder study (including the down titration phase for studies 168 and 169) and beginning treatment in study 248.
•Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device (IUD), or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception (e.g. Norplant System).
•Provide written informed consent for this study.
•Be willing and able to comply with study procedures.

Exclusion Criteria

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•Patients with any ongoing clinically significant adverse events at the end of the "feeder" studies.
•Subjects with severe, clinically significant condition(s) other than Parkinson's disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g., psychiatric, hematological, renal, hepatic, endocrinology, neurological (other than Parkinson's disease), cardiovascular, or active malignancy (other than basal cell carcinoma).
•Subjects with clinically significant abnormalities in Laboratory or ECG tests at the end of the feeder study (REQUIP study 165, 168 or 169).
•Subjects with severe dizziness or fainting due to postural hypotension on standing.
•Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit cytochrome P 450 1A2 (CYP1A2 \[e.g. ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol\]) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period.
•Women who are pregnant or breast-feeding.
•Use of an investigational drug throughout the treatment period.

Locations (75)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Englewood, Colorado, United States

GSK Investigational Site

Boca Raton, Florida, United States

GSK Investigational Site

Panama City, Florida, United States

GSK Investigational Site

Port Orange, Florida, United States

GSK Investigational Site

St. Petersburg, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

Key Dates

Start Date

February 1, 2004

Primary Completion Date

March 1, 2010

Completion Date

March 1, 2010

Last Updated

March 23, 2017

Enrollment

419

ACTUAL participants

Conditions

Parkinson DiseaseParkinson's Disease

Interventions

Ropinirole XL (formerly CR)

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

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RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGPHASE1

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

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