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

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ClinicalTrials.gov Identifier: NCT00632736
Recruitment Status : Completed
First Posted : March 11, 2008
Results First Posted : December 24, 2010
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Parkinson's Disease Drug: Ropinirole XL (formerly CR) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169
Study Start Date : February 2004
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ropinirole XL (formerly CR)
Ropinirole XL (formerly CR)
Drug: Ropinirole XL (formerly CR)



Primary Outcome Measures :
  1. 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 ]
    AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.


Secondary Outcome Measures :
  1. 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 ]
    The patient preference question assessed the participant's preference for either dosing regimen of study drug, once a day versus three times a day. Participants were asked to respond to the following question to assess preference: "Please indicate whether you preferred taking your Parkinson's tablets 3 times a day or once a day." Wk, Week.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632736


  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
San Francisco, California, United States, 94109
United States, Colorado
GSK Investigational Site
Englewood, Colorado, United States, 80110
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33486
GSK Investigational Site
Panama City, Florida, United States, 32405
GSK Investigational Site
Port Orange, Florida, United States, 32127
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
GSK Investigational Site
Tampa, Florida, United States, 33606
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Illinois
GSK Investigational Site
Glenview, Illinois, United States, 60025
United States, Kansas
GSK Investigational Site
Kansas City, Kansas, United States, 66160
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Michigan
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
GSK Investigational Site
Southfield, Michigan, United States, 48034
GSK Investigational Site
Traverse City, Michigan, United States, 49684
United States, New York
GSK Investigational Site
Albany, New York, United States, 12205
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27705
United States, Ohio
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Upland, Pennsylvania, United States, 19013
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Wichita Falls, Texas, United States, 76301
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53233
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Hasselt, Belgium, 3500
GSK Investigational Site
Hoboken, Belgium, 2660
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Roeselare, Belgium, 8800
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 656 91
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
GSK Investigational Site
Ostrava 10, Czech Republic, 710 00
GSK Investigational Site
Ostrava, Czech Republic, 703 52
GSK Investigational Site
Pardubice, Czech Republic, 535 03
GSK Investigational Site
Plzen - Lochotin, Czech Republic, 304 60
GSK Investigational Site
Prague, Czech Republic, 100 34
GSK Investigational Site
Praha 2, Czech Republic, 120 00
France
GSK Investigational Site
Aix en Provence, France, 13616
GSK Investigational Site
Lille Cedex, France, 59037
GSK Investigational Site
Rouffach, France, 68250
Hungary
GSK Investigational Site
Budapest, Hungary, 1083
GSK Investigational Site
Budapest, Hungary, 1096
GSK Investigational Site
Budapest, Hungary, 1135
GSK Investigational Site
Budapest, Hungary, 1145
GSK Investigational Site
Budapest, Hungary, 1204
GSK Investigational Site
Debrecen, Hungary, H-4012
GSK Investigational Site
Miskolc, Hungary, 3526
GSK Investigational Site
Miskolc, Hungary, 3529
GSK Investigational Site
Pécs, Hungary, 7623
GSK Investigational Site
Vasvari Pal street 2, H=9023 Gyor, Hungary
Italy
GSK Investigational Site
Pescara, Abruzzo, Italy, 65100
GSK Investigational Site
Pozzilli (IS), Molise, Italy, 86077
GSK Investigational Site
Grosseto, Toscana, Italy, 58100
GSK Investigational Site
Lido Di Camaiore (LU), Toscana, Italy, 55043
GSK Investigational Site
Vicenza, Veneto, Italy, 36057
Poland
GSK Investigational Site
Bialystok, Poland, 15-276
GSK Investigational Site
Ciborz, Poland, 66-212
GSK Investigational Site
Gdansk, Poland, 80-211
GSK Investigational Site
Gdansk, Poland, 80-299
GSK Investigational Site
Katowice, Poland, 40-752
GSK Investigational Site
Krakow, Poland, 31-530
GSK Investigational Site
Leszno, Poland, 64-100
GSK Investigational Site
Lublin, Poland, 20-718
GSK Investigational Site
Lublin, Poland, 20-954
GSK Investigational Site
Poznan, Poland, 61-285
GSK Investigational Site
Torun, Poland, 87-100
GSK Investigational Site
Warsaw, Poland, 02-097
GSK Investigational Site
Warszawa, Poland, 01-337
Spain
GSK Investigational Site
Barcelona, Spain, 08025
United Kingdom
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G51 4TF
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY3 8BP
GSK Investigational Site
Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE
GSK Investigational Site
Chertsey, Surrey, United Kingdom, KT16 0QA
GSK Investigational Site
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 101468/248
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 101468/248
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 101468/248
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 101468/248
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 101468/248
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 101468/248
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 101468/248
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00632736     History of Changes
Other Study ID Numbers: 101468/248
First Posted: March 11, 2008    Key Record Dates
Results First Posted: December 24, 2010
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
ropinirole XL
REQUIP
Parkinson's disease
long term safety
efficacy
safety
ropinirole CR
ropinirole IR
open-label

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs