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

This study has been completed.

First Received: July 25, 2006 Last Updated: March 19, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00357669

Purpose

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

Condition	Intervention	Phase
Unverricht-Lundborg Disease	Drug: Brivaracetam (ucb 34714)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	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 With Genetically Ascertained ULD

Resource links provided by NLM:

Drug Information available for: Brivaracetam

Further study details as provided by UCB:

Primary Outcome Measures:

Efficacy of BRV on the symptom relief of myoclonus. The change in scores of action myoclonus (Section 4) of the Unified Myoclonus Rating Scale at 4, 8 and 14 weeks.

Secondary Outcome Measures:

The scores on sections 1 (Myoclonus Patient Questionnaire), 3 (Stimulus sensitivity) and 5 (Functional disability test) of the Unified Myoclonus Rating Scale at 4, 8 and 14 weeks.

Enrollment:	50
Study Start Date:	November 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357669

Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

Dr. Philipp von Rosenstiel

UCB S.A.

More Information

No publications provided

Study ID Numbers:	N01187, RPCE06C2321
Study First Received:	July 25, 2006
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00357669 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by UCB:

Unverricht-Lundborg disease
Baltic myoclonus
progressive myoclonic epilepsies
myoclonus
brivaracetam

Study placed in the following topic categories:

Epilepsies, Myoclonic
Myoclonus
Myoclonus Epilepsy
Unverricht-Lundborg Syndrome
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn

Epilepsy
Central Nervous System Diseases
Myoclonic Epilepsies, Progressive
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Epilepsies, Myoclonic
Unverricht-Lundborg Syndrome
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Epilepsy

Nervous System Diseases
Central Nervous System Diseases
Myoclonic Epilepsies, Progressive
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on July 06, 2009