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Ropinirole Tablets In Young Patients With Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00140712
First received: August 31, 2005
Last updated: May 26, 2011
Last verified: May 2011
History of Changes

August 31, 2005
May 26, 2011
June 2005
December 2007   (final data collection date for primary outcome measure)
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). [ Designated as safety issue: Yes ]
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).
Complete list of historical versions of study NCT00140712 on ClinicalTrials.gov Archive Site
PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy. [ Designated as safety issue: No ]
PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC : ropinirole AUC. PD - Leg movement as measured by actigraphy.
Not Provided
Not Provided
 
Ropinirole Tablets In Young Patients With Restless Legs Syndrome
An Open Label, Single Dose, Dose Rising, Multi-centre Study to Assess the Tolerability and Pharmacokinetics of Ropinirole Immediate Release in Adolescent Patients With RLS.

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Restless Legs Syndrome
  • Restless Legs Syndrome (RLS)
Drug: Ropinirole Immediate Release
Other Name: Ropinirole Immediate Release
Experimental: Ropinirole
single dose .25mg of IR formulation, .05mg of RLS controlled release
Intervention: Drug: Ropinirole Immediate Release
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   France
 
NCT00140712
101468/253
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP