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

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00368251

Purpose

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

Condition	Intervention	Phase
Unverricht-Lundborg Disease	Drug: Brivaracetam Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) 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:	56
Study Start Date:	November 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (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 5mg/day BRV 5mg/day	Drug: Brivaracetam 2.5mg tablet, 5mg bid, 12 weeks (after 2 week up-titration period) Other Name: ucb34714
Experimental: Brivaracetam 150mg/day BRV 150mg/day	Drug: Brivaracetam 25mg and 50mg tablets, 150mg bid, 12 weeks (after 2 week up-titration period)

Eligibility

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

Criteria

Inclusion Criteria:

Subjects with diagnosed Unverricht-Lundborg disease (ULD) ascertained by appropriate genetic testing.

Exclusion Criteria:

Patients who never received adequate treatment before, i.e. with Valproic Acid (VPA) or Clonazepam (CZP)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368251

Locations

United States, California

San Francisco, California, United States
United States, New York

New York, New York, United States
United States, Virginia

Charlottesville, Virginia, United States
Canada, British Columbia

Vancouver, British Columbia, Canada
Canada, Quebec

Montreal, Quebec, Canada
Canada

Quebec, Canada
Finland

Helsinki, Finland
France

Bron, France

Lille, France

Paris, France
Israel

Tel Aviv, Israel
Russian Federation

Moscow, Russian Federation

Samara, Russian Federation
Serbia

Belgrade, Serbia

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:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00368251 History of Changes
Other Study ID Numbers:	N01236, RPCE06C2320
Study First Received:	August 23, 2006
Last Updated:	September 2, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; 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