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.

Condition	Intervention	Phase
Restless Legs Syndrome	Drug: Ropinirole Immediate Release	Phase I

Further Study Details: 

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).
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.
Expected Total Enrollment:  20

Ages Eligible for Study:  12 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Adolescent subjects diagnosed with probable or definite 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00140712

District of Columbia
      GSK Clinical Trials Call Center, Washington,  District of Columbia,  DC 20010,  United States; Recruiting
Kentucky
      GSK Clinical Trials Call Center, Louisville,  Kentucky,  KY 40202,  United States; Recruiting
Missouri
      GSK Clinical Trials Call Center, Kansas City,  Missouri,  MO 64108,  United States; Recruiting
New Jersey
      GSK Clinical Trials Call Center, Edison,  New Jersey,  NJ 08818,  United States; No longer recruiting
North Carolina
      GSK Clinical Trials Call Center, Chapel Hill,  North Carolina,  NC 27599-7220,  United States; Recruiting
Belgium
      GSK Clinical Trials Call Center, Brussels,  1020 Brussels,  Belgium; Recruiting
France
      GSK Clinical Trials Call Center, Paris,  75019 Paris,  France; Not yet recruiting

Study chairs or principal investigators

GSK Clinical Trials, MD,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  SK&F101468/253
Last Updated:  August 31, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00140712
Health Authority: United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines; France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-06