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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00699283 |
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 |
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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. |
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 |
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BRV 1: Experimental
50mg daily
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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)
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BRV 2: Experimental
100mg daily
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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)
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Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: UCB Clinical Trial Call Center | +1-877-822-9493 |
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
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 |
Epilepsy; Monotherapy Partial Onset Seizures Adults and Adolescents |
Epilepsy Seizures Neoplasm Metastasis Central Nervous System Diseases Brain Diseases |
Epilepsy Nervous System Diseases Central Nervous System Diseases Brain Diseases |