NCT02187809

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

Multi-site, Prospective, Open-label, Long-term, Flexible Dose, Interventional Study to Evaluate the Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

Summary

To investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.

Conditions

• Dravet Syndrome

Interventions

Type	Name	Description
DRUG	Clobazam

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-07-11
• Last updated: 2017-03-27
• Results posted: 2017-02-15

Locations

9 sites across 2 countries: United States, Mexico