Clinical Trial: Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patie

Brief Summary: The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.

Detailed Summary:
Sponsor: UCB Pharma SA

Current Primary Outcome: Percent reduction from baseline on the Action Myoclonus score (Unified Myoclonus Rating Scale (UMRS) Section 4) at the end of the Treatment Period [ Time Frame: End of treatment period (Week 14 or early discontinuation visit) ]

Original Primary Outcome: Efficacy of BRV on the symptom relief of myoclonus. The change in scores of action myoclonus (Section 4) of the Unified Myoclonus Rating Scale at 4, 8 and 14 weeks.

Current Secondary Outcome:

  • Percent reduction from baseline on the functional disability score (UMRS Section 5) at the end of the Treatment Period [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ]
  • Percent reduction from baseline on the stimulus sensitivity score (UMRS Section 3) at the end of the Treatment Period [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ]
  • Percent reduction from baseline on the myoclonus patient questionnaire (UMRS Section 1) at the end of the Treatment Period [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ]
  • Global Evaluation Scale by Investigator (I-GES) at the end of the Treatment Period [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ]


Original Secondary Outcome: The scores on sections 1 (Myoclonus Patient Questionnaire), 3 (Stimulus sensitivity) and 5 (Functional disability test) of the Unified Myoclonus Rating Scale at 4, 8 and 14 weeks.

Information By: UCB Pharma

Dates:
Date Received: July 25, 2006
Date Started: November 2006
Date Completion:
Last Updated: May 15, 2015
Last Verified: May 2015