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Protocol Summary for ROR104836

Protocol Summary
Protocol Id: ROR104836
Secondary Ids:
  • N/A
Title: A parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome.
Phase: phase 4
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Germany: Federal Institute for Drugs and Medical Devices
Collaborators:
  • N/A
Brief Summary: This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.
Detailed Description: A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome.
Record Verification Date: March 2011
Status: Completed
Why Study Stopped:
Study Start Date: March 2006
Study Completion Date: September 2008
Study Completion Date Type: Actual
Primary Completion Date: September 2008
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Evaluation of efficacy of ropinirole in moderate to severe Restless Legs Syndrome at Weeks 12 and 26 using the International Restless Legs Syndrome Rating Scale.Frequency of clinically meaningful augmentation and early morning rebound of symptoms. 26 weeks
Secondary Outcomes:
  • Proportion of subjects withdrawing due to lack of efficacy during the first 26 weeks. 26 Weeks
  • Evaluation of efficacy of ropinirole over 66 weeks of treatment.Incidence of confirmed cases of augmentation (worsening of symptoms). 66 Weeks
  • Change from baseline in the IRLS Rating Scale total score at Weeks 1, 4, 8, 16, and 20. 66 Weeks
  • Change from baseline in the Johns Hopkins RLS Quality of Life (RLS QoL) Questionnaire overall life impact score at Weeks 12 and 26. 26 Weeks
  • Change from baseline in the domains of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale at Weeks 12 and 26. 26 Weeks
  • Open-label phaseProportion of subjects with a score of much improved (2) or very much improved (1) on the CGI-I scale at Weeks 28, 31, 35, 39, 47, 55, 63, and 67. 40 Weeks
  • Change from baseline in the IRLS Rating Scale total score at Weeks 28, 31, 35, 39, 47, 55, 63, and 67. 40 Weeks
  • Time to first response during the double-blind phase, where response is defined as a score of much improved (2) or very much improved (1) on the CGI-I scale. 26 Weeks
  • Double-blind phaseProportion of subjects with a score of much improved (2) or very much improved (1) on the Clinical Global Impression – Global Improvement (CGI-I) scale at Weeks 1, 12, and 26. 66 Weeks
  • Change from baseline in the domains of the MOS 36-item Short Form Health Survey (SF-36) at Weeks 12 and 26. 26 Weeks
  • Clinical Global Impression - Severity of Illness (CGI-S) scale at Week 26. 26 Weeks
Conditions:
  • Restless Legs Syndrome
Keywords:
  • Moderate
  • Restless Legs Syndrome
  • Severe
  • ropinirole
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 79 Year
Enrollment: 404
Enrollment Type: Actual
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