Ropinirole Tablets In Young Patients With Restless Legs Syndrome
A Study to Determine the Tolerability and Pharmacokinetics for Ropinirole in Paediatric / Adolescent Patients With RLS (Type 2)
1 other identifier
interventional
9
3 countries
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2005
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2008
CompletedSeptember 11, 2017
September 1, 2017
2.7 years
August 31, 2005
September 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Up to 3 years
Secondary Outcomes (1)
PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.
Up to 3 years
Study Arms (1)
Ropinirole
EXPERIMENTALsingle dose .25mg of IR formulation, .05mg of RLS controlled release
Interventions
Eligibility Criteria
You may qualify if:
- Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (9)
GSK Investigational Site
Washington D.C., District of Columbia, 20010, United States
GSK Investigational Site
Macon, Georgia, 31201, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Kansas City, Missouri, 64108, United States
GSK Investigational Site
Edison, New Jersey, 08818, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Brussels, 1020, Belgium
GSK Investigational Site
Paris, 75019, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 1, 2005
Study Start
June 10, 2005
Primary Completion
February 28, 2008
Study Completion
February 28, 2008
Last Updated
September 11, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.