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

Completed · Phase 3 · Has a placebo group

Conditions studied: Unverricht-Lundborg Disease

In brief

The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).

Key facts

Study ID: NCT00368251
Run by: UCB Pharma
People needed: 56
Starts: 2006-11-01
Expected to finish: 2008-01-01
Last updated by the study team: 2023-05-31

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with diagnosed Unverricht-Lundborg disease (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 Myoclonussum 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

You may not qualify if…

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

Where it is running

135 — San Francisco, California, United States
133 — Gainesville, Florida, United States
132 — New York, New York, United States
131 — Charlottesville, Virginia, United States
151 — Vancouver, British Columbia, Canada
150 — Montreal, Quebec, Canada
152 — Québec, Quebec, Canada
100 — Helsinki, Finland
122 — Bron, France
121 — Lille, France
120 — Paris, France
170 — Tel Aviv, Israel
141 — Moscow, Russia
142 — Saint Petersburg, Russia
143 — Samara, Russia
161 — Belgrade, Serbia
162 — Belgrade, Serbia
180 — Manouba, Tunisia

Full record on ClinicalTrials.gov

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