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Completed

NCT Number: NCT00357669

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

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

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Key information

Conditions

Unverricht-Lundborg Disease Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Epilepsies, Myoclonic Epilepsy Epilepsy, Generalized Epileptic Syndromes Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Myoclonic Epilepsies, Progressive Myoclonus Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unverricht-Lundborg Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kuopio, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivaracetam 25 mg

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

Other names: ucb34714

Brivaracetam 50 mg

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

Other names: ucb34714

Placebo

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

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

UCB Pharma SA

Industry

Registry information

Official study 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 Patients (≥16 Years) With Genetically Ascertained Unverricht-Lundborg Disease

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 27, 2006
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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