Trials / Withdrawn
WithdrawnNCT02174094
Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
Multi-site, Prospective, Randomised, Double-blind, Placebo-controlled, Parallel-group, Interventional Study to Evaluate the Efficacy, Safety, and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- H. Lundbeck A/S · Industry
- Sex
- All
- Age
- 1 Year – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Clobazam | |
| DRUG | Placebo |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2014-06-25
- Last updated
- 2015-09-24
Locations
9 sites across 2 countries: United States, Mexico
Source: ClinicalTrials.gov record NCT02174094. Inclusion in this directory is not an endorsement.