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

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

Genetics Home Reference related topics:

familial encephalopathy with neuroserpin inclusion bodies pyridoxal 5'-phosphate-dependent epilepsy Unverricht-Lundborg disease

U.S. FDA Resources

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

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:

Subjects with diagnosed ULD ascertained by appropriate genetic testing.

Exclusion Criteria:

Patients who never received adequate treatment before, i.e. with VPA or CZP

Contacts and Locations

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

Locations


Finland

	Kuopio, Finland

	Tampere, Finland

France

	Marseille, France

	Montpellier Cedex 5, France

Italy

	Bologna, Italy

	Messina, Italy

	Milano, Italy

	Napoli, Italy

Netherlands

	Heemstede, Netherlands

	Heeze, Netherlands

Réunion

	St Pierre Cedex, Réunion

Sweden

	Goteborg, Sweden

Tunisia

	Tunis, Tunisia

Sponsors and Collaborators

UCB

Investigators


Study Director:	Dr. Philipp von Rosenstiel	UCB S.A.

More Information

Study ID Numbers:	N01187, RPCE06C2321
First Received:	July 25, 2006
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00357669
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

Unverricht-Lundborg Syndrome

Heredodegenerative Disorders, Nervous System

Myoclonus epilepsy

Genetic Diseases, Inborn

Epilepsy

Central Nervous System Diseases

Myoclonic Epilepsies, Progressive

Neurodegenerative Diseases

Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008

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