Ropinirole Tablets In Young Patients With Restless Legs Syndrome

• ClinicalTrials.gov Identifier: NCT00140712
• Recruitment Status: Completed
• First Posted: September 1, 2005
• Last Update Posted: September 11, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Restless Legs Syndrome	Drug: Ropinirole Immediate Release	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Determine the Tolerability and Pharmacokinetics for Ropinirole in Paediatric / Adolescent Patients With RLS (Type 2)
• Actual Study Start Date: June 10, 2005
• Actual Primary Completion Date: February 28, 2008
• Actual Study Completion Date: February 28, 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ropinirole; single dose .25mg of IR formulation, .05mg of RLS controlled release	Drug: Ropinirole Immediate Release; Ropinirole Immediate Release

Outcome Measures

Primary Outcome Measures :

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). [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :

1. PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy. [ Time Frame: Up to 3 years ]

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, District of Columbia

GSK Investigational Site

Washington, D.C., District of Columbia, United States, 20010

United States, Georgia

GSK Investigational Site

Macon, Georgia, United States, 31201

United States, Illinois

GSK Investigational Site

Chicago, Illinois, United States, 60611

United States, Kentucky

GSK Investigational Site

Louisville, Kentucky, United States, 40202

United States, Missouri

GSK Investigational Site

Kansas City, Missouri, United States, 64108

United States, New Jersey

GSK Investigational Site

Edison, New Jersey, United States, 08818

United States, North Carolina

GSK Investigational Site

Chapel Hill, North Carolina, United States, 27599

Belgium

GSK Investigational Site

Bruxelles, Belgium, 1020

France

GSK Investigational Site

Paris, France, 75019

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Individual Participant Data Set 

Identifier: 101468/253
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 101468/253
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 101468/253
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 101468/253
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 101468/253
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 101468/253
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 101468/253
For additional information about this study please refer to the GSK Clinical Study Register

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00140712
• Other Study ID Numbers: 101468/253
• First Posted: September 1, 2005
• Last Update Posted: September 11, 2017
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

RLS; PLMS; Adolescent; Periodic Limb Movements of Sleep; Ropinirole

Additional relevant MeSH terms:

Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Disease; Pathologic Processes; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Ropinirole; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs