A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
NCT04715646 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2025-06-27
Summary
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Conditions
Interventions
- DRUG
-
Brivaracetam
Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses. Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral Oral solution Concentration: 10 mg/ml Route of administration: oral
Sponsors & Collaborators
-
UCB Biopharma SRL
lead INDUSTRY
Principal Investigators
-
UCB Cares · 001 844 599 2273 (UCB)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Month
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-11
- Primary Completion
- 2030-07-08
- Completion
- 2030-07-08
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Czechia
- France
- Germany
- Hungary
- Italy
- Japan
- Mexico
- Poland
- Spain
Study Locations
More Related Trials
-
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
-
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
NCT01339559 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy
NCT03083665 ·Status: COMPLETED ·Phase: PHASE3
-
Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
NCT01261325 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
NCT01964560 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
NCT04625101 ·Status: COMPLETED ·Phase: PHASE2
-
Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
NCT05301894 ·Status: TERMINATED ·Phase: PHASE2
-
Study to Look at How Effective Briviact is as add-on Treatment for Patients With Epilepsy With Partial Onset Seizures
NCT02687711 ·Status: COMPLETED
-
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
-
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
NCT00699283 ·Status: TERMINATED ·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
-
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
NCT06309966 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
NCT05067634 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
NCT00975715 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)
NCT04873869 ·Status: TERMINATED ·Phase: PHASE2
-
Long-term Safety and Tolerability of BHV-7000
NCT06443463 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
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
-
The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children
NCT05697614 ·Status: UNKNOWN ·Phase: PHASE4
-
A Pediatric Drug Study to Determine the Long-term Safety and Tolerability in Children and Adolescents (4-17 Years in Age) Taking the Drug
NCT03108729 ·Status: WITHDRAWN ·Phase: PHASE3
-
Safety, Tolerability, and Pharmacokinetic Study of Pregabalin in Pediatric Patients With Partial Onset Seizures
NCT00437281 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
NCT01051193 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Clinical Evaluation of BW430C in Epilepsy
NCT00395694 ·Status: COMPLETED ·Phase: PHASE3
-
Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy Subjects
NCT00918424 ·Status: APPROVED_FOR_MARKETING
-
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
-
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
NCT00988156 ·Status: COMPLETED ·Phase: PHASE3