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.

CB S.A.0 个研究点目标入组 42 人开始时间: 2006年8月25日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•.) 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

•.) 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
•.) Ongoing psychiatric disorder other than mild controlled disorder.

发起方

CB S.A.