A multicenter, 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. - ULD trial

Phase 1

• Conditions: Patients with genetically ascertained Unverricht-Lundborg disease (ULD).; MedDRA version: 8.1Level: LLTClassification code 10054894Term: Unverricht-Lundborg disease

• Registration Number: EUCTR2006-001536-46-FR
• Lead Sponsor: CB S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-25
• Study Completion: 2008-01-08
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

- Subjects with diagnosed ULD ascertained by appropriate genetic testing for a
homozygous or compound heterozygous mutation in the 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.
- Male/female subjects from 16 years onwards. Subjects under 18 years may only be
included where legally permitted and ethically accepted.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified