Conditions: Partial Onset Seizures
Keywords: Seizures oxcarbazepine child
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
This study is designed to provide short term efficacy and safety data of TRI476 in children with inadequately-controlled partial seizures. Patients will be randomized into either drug treatment or placebo group at 1:1 ratio, and receive their respective treatment for 8 weeks. The purpose of study is to confirm that TRI476 as adjunctive therapy is effective and safe.

Detailed description:

Arms:
arm 1: Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. arm 2: Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.

Interventions: intervention 1: TRI476 intervention 2: Placebo to TRI476 intervention 3: Benzodiazepines
Intervention descriptions: intervention 1: TRI476 oral suspension doses, based on body weight twice daily intervention 2: Placebo oral suspension, taken twice daily intervention 3: Benzodiazepines could be used as needed as rescue medication during the duration of the study.

Protocol document: