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

This study has been terminated.
(An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected)
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00699283
First received: June 12, 2008
Last updated: September 6, 2012
Last verified: September 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
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 July 24, 2014