An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease
NCT ID: NCT00632736
Last Updated: 2017-03-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
419 participants
INTERVENTIONAL
2004-02-29
2010-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT00650104
Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528
NCT01536574
Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's
NCT00363727
A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda
NCT01371682
Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa
NCT00381472
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ropinirole XL (formerly CR)
Ropinirole XL (formerly CR)
Ropinirole XL (formerly CR)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ropinirole XL (formerly CR)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
GSK Investigational Site
Augusta, Georgia, United States
GSK Investigational Site
Glenview, Illinois, United States
GSK Investigational Site
Kansas City, Kansas, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Bingham Farms, Michigan, United States
GSK Investigational Site
Southfield, Michigan, United States
GSK Investigational Site
Traverse City, Michigan, United States
GSK Investigational Site
Albany, New York, United States
GSK Investigational Site
Durham, North Carolina, United States
GSK Investigational Site
Toledo, Ohio, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Upland, Pennsylvania, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Wichita Falls, Texas, United States
GSK Investigational Site
Milwaukee, Wisconsin, United States
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Hasselt, , Belgium
GSK Investigational Site
Hoboken, , Belgium
GSK Investigational Site
Leuven, , Belgium
GSK Investigational Site
Roeselare, , Belgium
GSK Investigational Site
Brno, , Czechia
GSK Investigational Site
Hradec Králové, , Czechia
GSK Investigational Site
Ostrava, , Czechia
GSK Investigational Site
Ostrava, , Czechia
GSK Investigational Site
Pardubice, , Czechia
GSK Investigational Site
Plzen - Lochotin, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Aix-en-Provence, , France
GSK Investigational Site
Lille, , France
GSK Investigational Site
Rouffach, , France
GSK Investigational Site
Budapest, , Hungary
GSK Investigational Site
Budapest, , Hungary
GSK Investigational Site
Budapest, , Hungary
GSK Investigational Site
Budapest, , Hungary
GSK Investigational Site
Budapest, , Hungary
GSK Investigational Site
Debrecen, , Hungary
GSK Investigational Site
Miskolc, , Hungary
GSK Investigational Site
Miskolc, , Hungary
GSK Investigational Site
Pécs, , Hungary
GSK Investigational Site
Vasvari Pal Street 2, H=9023 Gyor, , Hungary
GSK Investigational Site
Pescara, Abruzzo, Italy
GSK Investigational Site
Pozzilli (IS), Molise, Italy
GSK Investigational Site
Grosseto, Tuscany, Italy
GSK Investigational Site
Lido Di Camaiore (LU), Tuscany, Italy
GSK Investigational Site
Vicenza, Veneto, Italy
GSK Investigational Site
Bialystok, , Poland
GSK Investigational Site
Cibórz, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Krakow, , Poland
GSK Investigational Site
Leszno, , Poland
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Poznan, , Poland
GSK Investigational Site
Torun, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom
GSK Investigational Site
Blackpool, Lancashire, United Kingdom
GSK Investigational Site
Newcastle upon Tyne, Northumberland, United Kingdom
GSK Investigational Site
Chertsey, Surrey, United Kingdom
GSK Investigational Site
Swansea, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Makumi CW, Asgharian A, Ellis J, Shaikh S, Jimenez T, VanMeter S. Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease. Int J Neurosci. 2016;126(1):30-8. doi: 10.3109/00207454.2014.991924. Epub 2014 Dec 27.
Study Documents
Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.
Document Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
Access external resources that provide additional context or updates about the study.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
101468/248
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.