Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
NCT01261325 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 768
Last updated 2022-07-22
Summary
This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.
Conditions
Interventions
- DRUG
-
Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period
- DRUG
-
Brivaracetam
Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period
- DRUG
-
Brivaracetam
Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period.
- DRUG
-
Antiepileptic drugs with market authorization available per country
Sponsors & Collaborators
-
UCB Pharma
lead INDUSTRY
Principal Investigators
-
UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2014-05-31
- Completion
- 2014-05-31
Countries
- United States
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Czechia
- Estonia
- Finland
- France
- Germany
- Hong Kong
- Hungary
- India
- Italy
- Japan
- Latvia
- Lithuania
- Mexico
- Netherlands
- Poland
- Puerto Rico
- Russia
- South Korea
- Spain
- Sweden
- Taiwan
- United Kingdom
Study Locations
More Related Trials
-
Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
NCT01364597 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT00698581 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
NCT06315322 ·Status: RECRUITING ·Phase: PHASE3
-
Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
NCT00422422 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
NCT06132893 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
NCT04715646 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
NCT05109234 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
NCT04666610 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
NCT06425159 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
NCT00152451 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
NCT06309966 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures
NCT00422110 ·Status: WITHDRAWN ·Phase: PHASE2/PHASE3
-
A Study of the Effectiveness, Safety, and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures.
NCT00740623 ·Status: COMPLETED ·Phase: PHASE3
-
Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy
NCT00232596 ·Status: COMPLETED ·Phase: PHASE3
-
Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.
NCT00175864 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures
NCT05159908 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
NCT00425282 ·Status: COMPLETED ·Phase: PHASE3
-
Long-term Safety and Tolerability of BHV-7000
NCT06443463 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
NCT00280059 ·Status: COMPLETED ·Phase: PHASE3
-
Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
NCT03350035 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy
NCT03739840 ·Status: TERMINATED ·Phase: PHASE3
-
A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil
NCT03695094 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients
NCT01422720 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Test the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adults With Drug-resistant Epilepsy
NCT03373383 ·Status: COMPLETED ·Phase: PHASE2
-
Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
NCT00235755 ·Status: COMPLETED ·Phase: PHASE3