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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
419

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ropinirole XL (formerly CR)
Drug: Ropinirole XL (formerly CR)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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