Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome
This study has been completed.
Information provided by:
First received: July 20, 2006
Last updated: March 10, 2011
Last verified: March 2011
The primary objective of this study is to assess the safety and tolerability of ropinirole XR in the long-term treatment (up to 52 weeks)of adults with RLS.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients With Restless Legs Syndrome (RLS)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Incidence/severity of adverse events Changes in vital signs Labs ECG Assessment of augmentation and rebound (worsening of RLS symptoms).
Secondary Outcome Measures:
- Change from baseline in IRLS Rating Scale total score CGI Scale scores Medical Outcomes Study Sleep Scale scores Other subject-reported health outcomes.
- Incidence and severity of adverse events.
- Changes in vital signs (blood pressure and pulse) and weight.
- Changes in laboratory assessments (hematology and clinical chemistry).
- Changes in electrocardiogram (ECG) parameters.
- Assessment of augmentation.
- Assessment of rebound.
- Change from baseline in the IRLS Rating Scale total score at Week 52 LOCF (last observation carried forward).
- Proportion of subjects with a score of much improved (2) or very much improved (1) on CGI-I at Week 52 LOCF.
- CGI Severity of Illness (CGI-S) at Week 52 LOCF.
- Change from baseline in the domains of the Medical Outcomes Study (MOS-12) Sleep Scale at Week 52 LOCF.
- Change from baseline in the overall life impact score of the RLS Quality of Life Questionnaire at Week 52 LOCF.
- Change from baseline in the anxiety and depression domains of the Hospital Anxiety and Depression (HADS) Scale at Week 52 LOCF.
- Change from baseline in the total score and domains of the Profile of Mood States (POMS) Scale Short Form at Week 52 LOCF.
- Change from baseline in the parameters for the work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) Questionnaire at Week 52 LOCF.
- Proportion of subjects satisfied with their treatment at Week 52 LOCF.
|Study Start Date:||October 2005|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Drug: Ropinirole Extended Release (XR)
Other Name: Ropinirole Extended Release (XR)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355641
Show 62 Study Locations
Show 62 Study Locations
Sponsors and Collaborators
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|