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Home > Protocol Summaries: Compounds > ropinirole > Protocol Summary for RRL106721

Protocol Summary for RRL106721

Protocol Summary
Protocol Id: RRL106721
Secondary Ids:
  • EudraCT:2005-006080-31
Title: A multicenter 3:1-randomized placebo-controlled double-blind Phase IIIb study on the effects of Ropinirole on mood/(subclinical) depression in the therapy of patients with moderate to severe idiopathic RLS in Germany
Phase: phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Germany: Federal Institute for Drugs and Medical Devices
Collaborators:
Brief Summary: Ropinirole has shown to improve mood in depressed patients as well as to improve the symptoms of Restless Legs Syndrome. Up to 40% of RLS patients suffer from mild depression, therefore it would be important for decisions no therapy to know whether a drug could improve both depressive and RLS symptoms.
Detailed Description:
Record Verification Date: May 2011
Status: Completed
Why Study Stopped:
Study Start Date: June 2006
Study Completion Date: December 2007
Study Completion Date Type: Actual
Primary Completion Date: December 2007
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: yes
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Efficacy Study
Primary Outcomes:
  • to compare efficacy of ropinirole and placebo on improving mood in patients with moderate to severe idiopathic RLS and some depressive symptoms, change on a depression rating scale after 12 weeks treatment with ropinirole versus placebo is measured.
Secondary Outcomes:
  • ·Change form baseline at week 12 in somnolence, as measured by the MOS sleep scale.
  • Changes from baseline in visual analogue scale score (patients own assessment of their overall health) to day 8, weeks 4, 8 and 12
  • ·Changes from baseline at week 12 in number of awakenings per night due to RLS symptoms.
  • ·Change from baseline at week 12 in all domains of the SF-36.
  • ·Changes from baseline at week 12 in number of days with RLS symptoms.
  • ·CGI improvement and severity at day 8, weeks 4, 8 and 12.
  • ·Change from baseline at week 12 in the overall life impact score on the RLS QOL Questionnaire.
  • ·Change from baseline at week 12 in Sleep II Index, as measured by MOS sleep scale.
  • ·Proportion of patients with a score of much-improved (2) or very much-improved (1) on the CGI (Global Improvement) scale at day 8, weeks 4, 8 and 12 LOCF (last observation carried forward).
  • ·Change from baseline at week 12 in sleep quantity, as measured by the MOS sleep scale.
  • The efficacy of ropinirole in improving mood in patient with different severities of depression will be measured. Also the efficacy of ropinirole in improving the symptoms of RLS and sleep will be assessed. Some endpoints will include safety measures.
  • ·Time to response on the Clinical Global Impression (Global Improvement) (CGI) scale.
Conditions:
  • Restless Legs Syndrome
Keywords:
  • RLS
  • placebo
  • mood
  • double-blind
  • restless legs syndrome
  • germany
  • randomised
  • ropinirole
  • depression
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 79 Year
Enrollment: 240
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