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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00699283

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 III

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

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Brivaracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by UCB:

Primary Outcome Measures:

The primary efficacy analysis variable is the cumulative exit rate at 112 days after the beginning of the baseline AED tapering phase. [ Time Frame: Approximately 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	178
Study Start Date:	August 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

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

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 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

Contacts

Contact: UCB Clinical Trial Call Center

+1-877-822-9493

Hide Study Locations

Locations

United States, California
	Recruiting
Newport Beach, California, United States
	Recruiting
Riverside, California, United States
	Recruiting
Stanford, California, United States
	Recruiting
Sacramento, California, United States
United States, Colorado
	Recruiting
Fort Collins, Colorado, United States
United States, Connecticut
	Recruiting
Waterbury, Connecticut, United States
	Recruiting
Danbury, Connecticut, United States
United States, Florida
	Recruiting
Gainesville, Florida, United States
United States, Georgia
	Recruiting
Atlanta, Georgia, United States
United States, Hawaii
	Recruiting
Honolulu, Hawaii, United States
United States, Indiana
	Recruiting
Danville, Indiana, United States
	Recruiting
Elkhart, Indiana, United States
United States, Maryland
	Recruiting
Waldorf, Maryland, United States
United States, Missouri
	Recruiting
Columbia, Missouri, United States
United States, New York
	Recruiting
Schenectady, New York, United States
United States, North Carolina
	Recruiting
Charlotte, North Carolina, United States
United States, Ohio
	Recruiting
Westerville, Ohio, United States
United States, Oklahoma
	Recruiting
Tulsa, Oklahoma, United States
United States, Pennsylvania
	Recruiting
Bethlehem, Pennsylvania, United States
	Recruiting
Jenkintown, Pennsylvania, United States
United States, Rhode Island
	Recruiting
Providence, Rhode Island, United States
United States, Texas
	Recruiting
Bedford, Texas, United States
	Recruiting
San Antonio, Texas, United States
United States, Utah
	Recruiting
Layton, Utah, United States
	Recruiting
Ogden, Utah, United States
United States, Vermont
	Recruiting
Burlington, Vermont, United States
United States, Virginia
	Recruiting
Bluefield, Virginia, United States
United States, Wisconsin
	Recruiting
Marshfield, Wisconsin, United States
Finland
	Recruiting
Tampere, Finland
France
	Recruiting
Bethune, France
	Recruiting
Nice, France
	Recruiting
Saint Brieuc, France
	Recruiting
Toulouse, France
	Recruiting
Lille, France
Germany
	Recruiting
Munchen, Germany
	Recruiting
Bielefeld, Germany
	Recruiting
Berlin, Germany
	Recruiting
Ulm, Germany
	Recruiting
Bernau, Germany
	Recruiting
Munster, Germany
Hungary
	Recruiting
Kecskemet, Hungary
	Recruiting
Budapest, Hungary
	Recruiting
Debrecen, Hungary
	Recruiting
Szeged, Hungary
Italy
	Recruiting
Pisa, Italy
	Recruiting
Torino, Italy
	Recruiting
Bergamo, Italy
	Recruiting
Messina, Italy
	Recruiting
Germaneto, Italy
Spain
	Recruiting
Madrid, Spain
	Recruiting
Zaragoza, Spain
	Recruiting
Murcia, Spain

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01306, RPCE07F1216
Study First Received:	June 12, 2008
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00699283 History of Changes
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Finland: National Agency for Medicines; 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:

Epilepsy; Monotherapy
Partial Onset Seizures
Adults and Adolescents

Study placed in the following topic categories:

Epilepsy
Seizures
Neoplasm Metastasis
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 14, 2009