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

March 21, 2017 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

419

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • 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
        • GSK Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • GSK Investigational Site
      • Hradec Kralove, Czech Republic, 500 05
        • GSK Investigational Site
      • Ostrava, Czech Republic, 703 52
        • GSK Investigational Site
      • Ostrava 10, Czech Republic, 710 00
        • 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
        • GSK Investigational Site
  • France
      • Aix en Provence, France, 13616
        • GSK Investigational Site
      • Lille Cedex, France, 59037
        • GSK Investigational Site
      • Rouffach, France, 68250
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1083
        • GSK Investigational Site
      • Budapest, Hungary, 1096
        • GSK Investigational Site
      • Budapest, Hungary, 1145
        • GSK Investigational Site
      • Budapest, Hungary, 1135
        • 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
        • GSK Investigational Site
  • Italy
    • Abruzzo
      • Pescara, Abruzzo, Italy, 65100
        • GSK Investigational Site
    • Molise
      • Pozzilli (IS), Molise, Italy, 86077
        • GSK Investigational Site
    • Toscana
      • Grosseto, Toscana, Italy, 58100
        • GSK Investigational Site
      • Lido Di Camaiore (LU), Toscana, Italy, 55043
        • GSK Investigational Site
    • Veneto
      • Vicenza, Veneto, Italy, 36057
        • GSK Investigational Site
  • Poland
      • 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
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08025
        • GSK Investigational Site
  • United Kingdom
      • Swansea, United Kingdom, SA6 6NL
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G51 4TF
        • GSK Investigational Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8BP
        • GSK Investigational Site
    • Northumberland
      • Newcastle Upon Tyne, Northumberland, United Kingdom, NE4 6BE
        • GSK Investigational Site
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0QA
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • GSK Investigational Site
    • California
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • San Francisco, California, United States, 94109
        • GSK Investigational Site
    • Colorado
      • Englewood, Colorado, United States, 80110
        • GSK Investigational Site
    • Florida
      • 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
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Augusta, Georgia, United States, 30912
        • GSK Investigational Site
    • Illinois
      • Glenview, Illinois, United States, 60025
        • GSK Investigational Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • GSK Investigational Site
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • GSK Investigational Site
      • Southfield, Michigan, United States, 48034
        • GSK Investigational Site
      • Traverse City, Michigan, United States, 49684
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • GSK Investigational Site
    • Ohio
      • Toledo, Ohio, United States, 43614-5809
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
      • Upland, Pennsylvania, United States, 19013
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
      • Wichita Falls, Texas, United States, 76301
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ropinirole XL (formerly CR)
Drug: Ropinirole XL (formerly CR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
13 February 2004 through 31 March 2010

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4 and Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 11, 2008

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101468/248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: 101468/248
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: 101468/248
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: 101468/248
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 101468/248
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: 101468/248
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: 101468/248
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: 101468/248
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Ropinirole XL (formerly CR)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe