Last updated: 11/02/2018 23:35:30

Ropinirole Tablets In Young Patients With Restless Legs Syndrome

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GSK study ID
101468/253
See study documents
Clinicaltrials.gov ID
NCT00140712
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 study to determine the tolerability and pharmacokinetics for ropinirole in paediatric / adolescent patients with RLS (Type 2)
Trial description: This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy).

Timeframe: Up to 3 years

Secondary outcomes:

PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.

Timeframe: Up to 3 years

Interventions:
  • Drug: Ropinirole Immediate Release
    • Enrollment:
    9
    Primary completion date:
    Not applicable
    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)
    June 2005 to February 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    12 - 17 years
    Accepts healthy volunteers
    No
    • Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).
    • Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or sleep, or to induce or treat alertness, including methylphenidate.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).
    Exclusion criteria:
    • Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or sleep, or to induce or treat alertness, including methylphenidate.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27599
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Macon, Georgia, United States, 31201
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20010
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bruxelles, Belgium, 1020
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Edison, New Jersey, United States, 08818
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60611
    Status
    Terminated/Withdrawn
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    Showing 1 - 6 of 9 Results

    Study documents

    Clinical study report
    Available language(s): English
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    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2008-28-02

    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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    Additional information
    Results for study 101468/253 can be found on the GSK Clinical Study Register.
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