Last updated: 11/02/2018 23:35:30
Ropinirole Tablets In Young Patients With Restless Legs Syndrome
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Macon, Georgia, United States, 31201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Edison, New Jersey, United States, 08818
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64108
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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
Participate in clinical trial
Additional information
Results for study 101468/253 can be found on the GSK Clinical Study Register.
Click hereResearchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website