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Home > Protocol Summaries: Compounds > ropinirole > Protocol Summary for 101468/249

Protocol Summary for 101468/249

Protocol Summary
Protocol Id: 101468/249
Secondary Ids:
Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS)
Phase: phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 63,172
IND/IDE Serial Number: 0039
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
Brief Summary: A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.
Detailed Description:
Record Verification Date: June 2012
Status: Completed
Why Study Stopped:
Study Start Date: August 2003
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Improvement in RLS severity rating scale at Week 12
Secondary Outcomes:
  • Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.
Conditions:
  • Restless Legs Syndrome
Keywords:
  • RLS
  • Ropinirole
  • sleep disorder
  • fatigue
  • Legs
  • Restless Legs Syndrome
  • sleep
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 79 Year
Enrollment: 360
Enrollment Type:
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
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