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

Overview

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

Full Title of Study: “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 Patients (≥16 Years) With Genetically Ascertained Unverricht-Lundborg Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2007

Interventions

  • Drug: Brivaracetam 25 mg
    • Active Substance: Brivaracetam Pharmaceutical Form: Tablet Concentration: 25 mg Route of Administration: Oral use
  • Drug: Brivaracetam 50 mg
    • Active Substance: Brivaracetam Pharmaceutical Form: Tablet Concentration: 50 mg Route of Administration: Oral use
  • Other: Placebo
    • Active Substance: Placebo Pharmaceutical Form: Tablet Concentration: 25 mg and 50 mg Route of Administration: Oral use

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: Brivaracetam 50 mg/day
    • BRV 50 mg/day
  • Experimental: Brivaracetam 150 mg/day
    • BRV 150 mg/day

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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)

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects with diagnosed Unverricht-Lundborg disease (ULD) ascertained by appropriate genetic testing for a homozygous or compound heterozygous mutation in the Cystatin B (CSTB) gene – Subjects with moderate to severe myoclonus documented by an Action Myoclonus sum score of ≥ 30 (evaluation by investigator) – Subjects currently being or having been treated with clonazepam up to the maximum recommended daily dose of 20 mg or up to their individual optimal dose as assessed by the investigator – Subjects currently being or having been treated with valproate up to the maximum recommended daily dose 60 mg/kg or serum levels of 100 mcg/ml or up to their individual optimal dose as specified by the investigator Exclusion Criteria:

  • Subjects currently on felbamate or having been on felbamate within less than 18 months prior to Visit 1 – Subjects currently treated with phenytoin or having been on phenytoin in the last month prior to Visit 1 – Subjects currently on vigabatrine. Subjects having been on vigabatrine if no visual fields examination report available including standard static (Humphrey or Octopus) or cinetic perimetry (Goldman) – Subject taking any drug with possible central nervous system (CNS) effects – Subjects taking any drug that may significantly influence the metabolism of BRV (CYP2C or CYP3A potent inducers/inhibitors) – Known clinically significant acute or chronic illness or illness which may impair reliable participation in the trial, necessitate the use of medication not allowed by protocol or represent a safety risk in the Investigator's opinion – Subjects with history of severe adverse hematological reaction to any drug – Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, GGT value of more than three times the upper limit of the reference range – History of suicide attempt during the last 5 years – Subject with suicidal ideations within the last year or at risk of suicide attempt unless cleared by written confirmation from a psychiatrist and approved by the UCB physician – Ongoing psychiatric disorder other than mild controlled disorder

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UCB Pharma SA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • UCB Clinical Trial Call Center, Study Director, +1 877 822 9493 (UCB)

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