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

Unverricht-Lundborg Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357669
• Other study ID #: N01187
• Secondary ID: 2006-000169-12
• Status: Completed
• Phase: Phase 3
• First received: July 25, 2006
• Last updated: May 15, 2015
• Start date: November 2006
• Est. completion date: October 2007

Study information

• Verified date: May 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unverricht-Lundborg Disease
• Unverricht-Lundborg Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma SA

Countries where clinical trial is conducted

Finland,  France,  Italy,  Netherlands,  Réunion,  Sweden,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction from baseline on the Action Myoclonus score (Unified Myoclonus Rating Scale (UMRS) Section 4) at the end of the Treatment Period		End of treatment period (Week 14 or early discontinuation visit)	No
Secondary	Percent reduction from baseline on the functional disability score (UMRS Section 5) at the end of the Treatment Period		End of treatment period (week 14 or early discontinuation visit)	No
Secondary	Percent reduction from baseline on the stimulus sensitivity score (UMRS Section 3) at the end of the Treatment Period		End of treatment period (week 14 or early discontinuation visit)	No
Secondary	Percent reduction from baseline on the myoclonus patient questionnaire (UMRS Section 1) at the end of the Treatment Period		End of treatment period (week 14 or early discontinuation visit)	No
Secondary	Global Evaluation Scale by Investigator (I-GES) at the end of the Treatment Period		End of treatment period (week 14 or early discontinuation visit)	No