Last updated: 07/18/2020 12:11:11

Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

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GSK study ID
ROX104805
See study documents
Clinicaltrials.gov ID
NCT00256854
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting from Ropinirole Immediate Release (IR) to Ropinirole Controlled Release for RLS (CR-RLS) Formulation (Formerly Ropinirole Extended Release [XR]) in Patients with Restless Legs Syndrome (RLS)
Trial description: This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Number of adverse events (AEs) post-conversion from ropinirole IR to ropinirole CR over period

Timeframe: Up to 5 weeks

Secondary outcomes:

Number of participants discontinuing the drug due to AEs post conversion from ropinirole IR to ropinirole CR-RLS

Timeframe: Up to 5 weeks

Number of participants with SAEs and severity of AEs

Timeframe: Up to 5 weeks

Number of participants with positive scores (improved) on clinical global impression improvement scale (CGI-I) pre-conversion and one week post-conversion

Timeframe: Up to 4 weeks

Change from pre-conversion in international RLS (IRLS) rating scale total score to one week post-conversion

Timeframe: Up to 5 weeks

Number of participants with pre-and one week post-conversion values of vital signs of potential clinical concern (PCC)

Timeframe: Up to 5 weeks

Change from pre-conversion in systolic and diastolic orthostatic SBP and DBP to one week post-conversion

Timeframe: Up to 5 weeks

Change from pre-conversion in pulse rate to one week post-conversion

Timeframe: Up to 5 weeks

Change from pre-conversion to post-conversion in ambulatory blood pressure

Timeframe: Up to 5 weeks

Interventions:
  • Drug: Ropinirole IR 1 mg
  • Drug: Ropinirole IR 2 mg
  • Drug: Ropinirole IR 1 mg Placebo
  • Drug: Ropinirole IR 2 mg Placebo
  • Drug: Ropinirole CR 2 mg
  • Drug: Ropinirole CR 3 mg
  • Drug: Ropinirole CR 2 mg Placebo
  • Drug: Ropinirole CR 3 mg Placebo
    • Enrollment:
    135
    Primary completion date:
    2006-21-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Restless Legs Syndrome
    Product
    ropinirole
    Collaborators
    Not applicable
    Study date(s)
    November 2005 to September 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 79 years
    Accepts healthy volunteers
    No
    • Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
    • Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
    • Subjects who require treatment of daytime RLS symptoms.
    • Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
    • Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
    • Subjects with RLS symptoms during both the evening and night or night time only.
    • Subjects who have given written informed consent to participate.
    Exclusion criteria:
    • Subjects who require treatment of daytime RLS symptoms.
    • Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
    • Movement Disorders, Clinically significant or unstable medical conditions.
    • Abnormal labs, electrocardiogram (ECG) or physical findings.
    • Receiving prohibited medications.
    • Sleeping habits incompatible with study design.
    • Intolerance to ropinirole or other dopamine agonist.
    • Pregnant or lactating.
    • Women of child-bearing potential who are not practicing an acceptable method of birth control.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tacoma, Washington, United States, 98405
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oak Brook, Illinois, United States, 60523
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Laguna Hills, California, United States, 82653
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cherry Hill, New Jersey, United States, 08003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lenexa, Kansas, United States, 66214
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boca Raton, Florida, United States, 33486
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504-8456
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dayton, Ohio, United States, 46432
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oxnard, California, United States, 93030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plainview, New York, United States, 11803
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pasadena, California, United States, 91106
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Reseda, California, United States, 91355
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lebanon, New Hampshire, United States, 03766
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53715
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75213
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greenville, North Carolina, United States, 27834
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Walla Walla, Washington, United States, 99362
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baton Rouge, Louisiana, United States, 70808
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89119
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33609
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Massachusetts, United States, 01104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, South Carolina, United States, 29201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bingham Farms, Michigan, United States, 48025
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toms River, New Jersey, United States, 08755
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Petersburg, Florida, United States, 33701
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-21-09
    Actual study completion date
    2006-21-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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