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Ropinirole Tablets In Young Patients With Restless Legs Syndrome
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00140712
First received: August 31, 2005
Last updated: September 8, 2017
Last verified: September 2017
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Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
restless legs syndrome
MedlinePlus related topics:
Restless Legs
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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:
- 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 ]
| Enrollment: | 9 |
| Actual Study Start Date: | June 10, 2005 |
| Study Completion Date: | February 28, 2008 |
| Primary Completion Date: | February 28, 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ropinirole
single dose .25mg of IR formulation, .05mg of RLS controlled release
|
Drug: Ropinirole Immediate Release
Ropinirole Immediate Release
|
Eligibility| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00140712
Please refer to this study by its ClinicalTrials.gov identifier: NCT00140712
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:
Study Data/Documents: Individual Participant Data Set
Identifier: 101468/253
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
Dataset Specification
Identifier: 101468/253
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
Informed Consent Form
Identifier: 101468/253
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
Annotated Case Report Form
Identifier: 101468/253
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
Statistical Analysis Plan
Identifier: 101468/253
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
Clinical Study Report
Identifier: 101468/253
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
Study Protocol
Identifier: 101468/253
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 History of Changes |
| Other Study ID Numbers: |
101468/253 |
| Study First Received: | August 31, 2005 |
| Last Updated: | September 8, 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. |
| URL: | http:// |
Keywords provided by GlaxoSmithKline:
|
RLS PLMS Adolescent Periodic Limb Movements of Sleep Ropinirole |
Additional relevant MeSH terms:
|
Syndrome Psychomotor Agitation Restless Legs Syndrome Disease Pathologic Processes Dyskinesias Neurologic Manifestations Nervous System Diseases Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms 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 |
ClinicalTrials.gov processed this record on September 19, 2017