Clinical Trial: Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Safety and Efficacy of Rasagiline in Restless Legs Syndrome

Brief Summary: The purpose of this study is to find out if rasagiline improves RLS symptoms. We also want to make sure rasagiline is safe to give people with RLS.

Detailed Summary:

The primary objective is to determine if rasagiline, at a dosage of 1mg/day, is non-futile for the treatment of RLS, as measured by the International RLS Study Group Rating Scale (IRLS). The primary outcome variable will be the change in IRLS from baseline to Week 12.

The secondary objectives are to determine if rasagiline, at a dosage of 1mg/day, is safe and well-tolerated in participants with RLS. Also, to determine if rasagiline improves measures of global clinical change, sleep quality, excessive sleepiness, quality of life, or depressive symptoms.


Sponsor: University of Virginia

Current Primary Outcome: Change in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score from Baseline to Week 12 [ Time Frame: Screening, Baseline, Week 6, Week 12 ]

The IRLS is a 10-question scale that contains questions about both the frequency and severity of RLS symptoms, as well as secondary aspects such as sleep quality and daytime tiredness.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tolerability (ability to complete study on assigned dosage) [ Time Frame: 12 weeks ]
  • Adverse events [ Time Frame: 12 weeks ]
  • Change in Beck Depression Inventory from Baseline to Week 12 [ Time Frame: Baseline, Week 6, Week 12 ]
  • Change in Clinical Global Impression - Change from Baseline to Weeks 12 [ Time Frame: Baseline, Week 6, Week 12 ]
  • Change in Medical Outcome Study Sleep Scale from Baseline to Week 12 [ Time Frame: Baseline, Week 6, Week 12 ]
  • Change in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire from Baseline to Week 12 [ Time Frame: Baseline, week 6, Week 12 ]
  • Change in Epworth Sleepiness Scale from Baseline to Week 12 [ Time Frame: Baseline, Week 6, Week 12 ]


Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: August 23, 2010
Date Started: September 2010
Date Completion:
Last Updated: February 8, 2013
Last Verified: February 2013