Ropinirole Tablets In Young Patients With Restless Legs Syndrome
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00140712 |
Recruitment Status :
Completed
First Posted : September 1, 2005
Last Update Posted : September 11, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Restless Legs Syndrome | Drug: Ropinirole Immediate Release | Phase 1 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140712
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 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

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 Key Record Dates |
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. |
RLS PLMS Adolescent Periodic Limb Movements of Sleep Ropinirole |
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 |