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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00368251

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 Drug: 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:

Primary Outcome Measures:

Efficacy of Brivaracetam 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. [ Time Frame: 12 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. [ Time Frame: 12 weeks ]

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
1: Placebo Comparator	Drug: Placebo Placebo
2: Experimental	Drug: Brivaracetam 2.5mg tablet, 5mg bid, 12 weeks
3: Experimental	Drug: Brivaracetam 25mg and 50mg tablets, 150mg bid, 12 weeks

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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 and Montenegro

Belgrade, Serbia and Montenegro

Sponsors and Collaborators

UCB

Investigators

Study Director:

Dr. Philipp von Rosenstiel

Clinical Program Director Therapeutic Area Neurology/Psychiatry UCB S.A.

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:	March 19, 2008
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:

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