A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures - Full Text View

Purpose

Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.

Condition	Intervention	Phase
Epilepsy	Drug: Brivaracetam	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization.

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

The primary efficacy analysis variable is the Cumulative Exit Rate at 112 days after the beginning of the Baseline Antiepileptic Drug (AED) tapering phase [ Time Frame: From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks) ] [ Designated as safety issue: No ]
The Cumulative Exit Rate of subjects who have exited the study at 16 weeks or 112 days after the beginning of the Baseline AED tapering phase (at Visit 4) will be compared to the historical lower bound estimate of the 80% prediction interval (computed assuming a sample size of 50 subjects) of the cumulative rate of subjects who have exited the study. This lower bound historical estimate is computed to be 0.74.

Enrollment:	62
Study Start Date:	August 2008
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Brivaracetam (BRV) 1 50 mg daily	Drug: Brivaracetam 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study) Other Name: ucb 34714
Experimental: Brivaracetam (BRV) 2 100 mg daily	Drug: Brivaracetam 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study) Other Name: ucb 34714

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects from 16 to 75 years, both inclusive
Well-characterized focal epilepsy or epileptic syndrome
Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50% of the minimum recommended maintenance dose

Exclusion Criteria:

Seizure type IA non-motor as only seizure type
History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
Other serious uncontrolled disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699283

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Locations

United States, Arkansas

Little Rock, Arkansas, United States
United States, California

Garden Grove, California, United States

Loma Linda, California, United States

Newport Beach, California, United States

Riverside, California, United States

Sacramento, California, United States

Stanford, California, United States
United States, Colorado

Denver, Colorado, United States

Fort Collins, Colorado, United States
United States, Connecticut

Danbury, Connecticut, United States

New Haven, Connecticut, United States

Waterbury, Connecticut, United States
United States, Florida

Gainesville, Florida, United States

Miami, Florida, United States
United States, Georgia

Atlanta, Georgia, United States
United States, Hawaii

Honolulu, Hawaii, United States
United States, Illinois

Chicago, Illinois, United States
United States, Indiana

Danville, Indiana, United States

Elkhart, Indiana, United States
United States, Maryland

Waldorf, Maryland, United States
United States, Michigan

Grand Rapids, Michigan, United States
United States, Missouri

Columbia, Missouri, United States
United States, New Hampshire

Lebanon, New Hampshire, United States
United States, New Mexico

Albuquerque, New Mexico, United States
United States, New York

Flushing, New York, United States

Schenectady, New York, United States
United States, North Carolina

Charlotte, North Carolina, United States
United States, Ohio

Oberlin, Ohio, United States

Westerville, Ohio, United States
United States, Oklahoma

Tulsa, Oklahoma, United States
United States, Pennsylvania

Bethlehem, Pennsylvania, United States

Jenkintown, Pennsylvania, United States
United States, Rhode Island

Providence, Rhode Island, United States
United States, Texas

Austin, Texas, United States

Bedford, Texas, United States

San Antonio, Texas, United States
United States, Utah

Layton, Utah, United States

Ogden, Utah, United States
United States, Vermont

Burlington, Vermont, United States
United States, Virginia

Bluefield, Virginia, United States
United States, Washington

Seattle, Washington, United States
United States, West Virginia

Morgantown, West Virginia, United States
United States, Wisconsin

Marshfield, Wisconsin, United States
France

Bethune, France

Lille, France

Saint Brieuc, France

Toulouse, France
Germany

Berlin, Germany

Bernau, Germany

Bielefeld, Germany

Munchen, Germany

Munster, Germany

Ulm, Germany
Hungary

Budapest, Hungary

Debrecen, Hungary

Kecskemet, Hungary

Szeged, Hungary
Italy

Bergamo, Italy

Firenze, Italy

Germaneto, Italy

Messina, Italy

Perugia, Italy

Pisa, Italy

Torino, Italy
Spain

Barcelona, Spain

Madrid, Spain

Murcia, Spain

Zaragoza, Spain

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:	NCT00699283 History of Changes
Other Study ID Numbers:	N01306, RPCE07F1216
Study First Received:	June 12, 2008
Last Updated:	September 6, 2012
Health Authority:	United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: Ministry of Health Spain: Ministry of Health

Keywords provided by UCB, Inc.:

Epilepsy; Monotherapy
Partial Onset Seizures
Adults and Adolescents

Additional relevant MeSH terms:

Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013