drugset / Trial / NCT02174094

Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

NCT02174094

Phase 3 Withdrawn H. Lundbeck A/S
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.

Timeline

Start
2015-03
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Clobazam Small molecule 1 mg/kg Oral
Subject Clobazam Small molecule 1.5 mg/kg Oral
Subject Clobazam Small molecule 2 mg/kg Oral

Indications