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:	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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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, 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: Placebo Comparator	Other: Placebo Placebo bid, 14 weeks (2 week up-titration period + 12 week maintenance period)
Brivaracetam 5mg/day: Experimental BRV 5mg/day	Drug: Brivaracetam 2.5mg tablet, 5mg bid, 12 weeks (after 2 week up-titration period)
Brivaracetam 150mg/day: Experimental BRV 150mg/day	Drug: Brivaracetam 25mg and 50mg tablets, 150mg bid, 12 weeks (after 2 week up-titration period)

Eligibility

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

Quebec, Canada
Canada, British Columbia

Vancouver, British Columbia, Canada
Canada, Quebec

Montreal, Quebec, Canada
Finland

Helsinki, Finland
France

Lille, France

Bron, 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 ( UCB Clinical Trial Call Center )
Study ID Numbers:	N01236, RPCE06C2320
Study First Received:	August 23, 2006
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00368251 History of Changes
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:

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 November 25, 2009