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

May 15, 2015 updated by: UCB Pharma SA

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland
      • Tampere, Finland
  • France
      • Marseille, France
      • Montpellier Cedex 5, France
  • Italy
      • Bologna, Italy
      • Messina, Italy
      • Milano, Italy
      • Napoli, Italy
  • Netherlands
      • Heemstede, Netherlands
      • Heeze, Netherlands
  • Réunion
      • St Pierre Cedex, Réunion
  • Sweden
      • Goteborg, Sweden
  • Tunisia
      • Tunis, Tunisia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
  • Active Substance: Placebo Pharmaceutical Form: Tablet
  • Concentration: 25 mg and 50 mg
  • Route of Administration: Oral use
Experimental: Brivaracetam 50 mg/day
BRV 50 mg/day
Drug: Brivaracetam 25 mg
  • Active Substance: Brivaracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 25 mg
  • Route of Administration: Oral use
Other Names:
  • ucb34714
Drug: Brivaracetam 50 mg
  • Active Substance: Brivaracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 50 mg
  • Route of Administration: Oral use
Other Names:
  • ucb34714
Experimental: Brivaracetam 150 mg/day
BRV 150 mg/day
Drug: Brivaracetam 25 mg
  • Active Substance: Brivaracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 25 mg
  • Route of Administration: Oral use
Other Names:
  • ucb34714
Drug: Brivaracetam 50 mg
  • Active Substance: Brivaracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 50 mg
  • Route of Administration: Oral use
Other Names:
  • ucb34714

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
End of treatment period (Week 14 or early discontinuation visit)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
End of treatment period (week 14 or early discontinuation visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 25, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01187
  • 2006-000169-12 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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