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 Drug: Placebo	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 (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

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

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: 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

Responsible Party:	UCB ( UCB Clinical Trial Call Center )
Study ID Numbers:	N01236, RPCE06C2320
First Received:	August 23, 2006
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00368251
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

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 15, 2008

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