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Home > Protocol Summaries: Compounds > ropinirole > Protocol Summary for 101468/205

Protocol Summary for 101468/205

Protocol Summary
Protocol Id: 101468/205
Secondary Ids:
  • SK&F-101468/205
Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome
Phase: Phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 70,140
IND/IDE Serial Number: 0000
Has Expanded Access?:
Study Type: interventional
Oversight Authority:
  • United States: Food and Drug Administration
  • Canada: Health Canada
Collaborators:
Brief Summary: The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).
Detailed Description:
Record Verification Date: October 2009
Status: Completed
Why Study Stopped:
Study Start Date: June 2005
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12. 12 Weeks
Secondary Outcomes:
  • Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12. 12 Weeks
Conditions:
  • Restless Legs Syndrome
Keywords:
  • Restless Legs Syndrome
  • RLS
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: 79 Years
Enrollment: 380
Enrollment Type:
Healthy Volunteers?: no
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information