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 is currently recruiting participants.

Verified by UCB, August 2009

First Received: June 12, 2008 Last Updated: August 13, 2009 History of Changes

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

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.

Resource links provided by NLM:

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

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

Show 65 Study Locations

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:	August 13, 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 August 28, 2009