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

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
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 Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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:

Genetics Home Reference related topics: PRICKLE1-related progressive myoclonus epilepsy with ataxia pyridoxal 5'-phosphate-dependent epilepsy Unverricht-Lundborg disease

MedlinePlus related topics: Epilepsy

Drug Information available for: Brivaracetam

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Percent reduction from baseline on the Action Myoclonus score (Unified Myoclonus Rating Scale (UMRS) Section 4) [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent reduction from baseline on the functional disability score (UMRS Section 5) [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ] [ Designated as safety issue: No ]
Percent reduction from baseline on the stimulus sensitivity score (UMRS Section 3) [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ] [ Designated as safety issue: No ]
Percent reduction from baseline on the myoclonus patient questionnaire (UMRS Section 1) [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ] [ Designated as safety issue: No ]

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)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Other: Placebo Placebo bid, 14 weeks (2 week up-titration period + 12 week maintenance period)
Experimental: Brivaracetam 50mg/day BRV 50mg/day	Drug: Brivaracetam 25mg tablet, 50mg bid, 12 weeks (after 2 week up-titration period) Other Name: ucb34714
Experimental: Brivaracetam 150mg/day BRV 150mg/day	Drug: Brivaracetam 25 and 50mg tablets, 150 mg bid, 12 weeks (after 2 week up-titration period) Other Name: ucb34714

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	Study Director, UCB
ClinicalTrials.gov Identifier:	NCT00357669 History of Changes
Other Study ID Numbers:	N01187, RPCE06C2321
Study First Received:	July 25, 2006
Last Updated:	August 4, 2009
Health Authority:	European Union: European Medicines Agency

Keywords provided by UCB, Inc.:

Unverricht-Lundborg disease
Baltic myoclonus
progressive myoclonic epilepsies
myoclonus
brivaracetam

Additional relevant MeSH terms:

Unverricht-Lundborg Syndrome
Myoclonic Epilepsies, Progressive
Epilepsies, Myoclonic
Epilepsy
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 12, 2012