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

Stopped early · Phase 3

Conditions studied: Dravet Syndrome

In brief

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.

Key facts

Study ID: NCT02187809
Run by: H. Lundbeck A/S
People needed: 3
Starts: 2015-03-01
Expected to finish: 2015-10-01
Last updated by the study team: 2017-03-27

Who can join

Age: 1 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

The patient has a diagnosis of Dravet Syndrome supported by:
onset of seizures in the first year of life
history of fever-induced prolonged seizures as determined by the Investigator
these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures
multiple seizure types which may include:
generalised tonic-clonic (required for inclusion)
clonic (required for inclusion)
myoclonic jerks/seizures
history of normal development prior to seizure onset followed by development delay or regression after seizure onset
abnormal EEG consistent with Dravet Syndrome
The patient is currently receiving a stable dose of clobazam of at least 0.5 mg/kg/day (maximum 20 mg/day) for at least 3 months
Other protocol-defined inclusion and exclusion criteria may apply.

Where it is running

US010 — Los Angeles, California, United States
US012 — Orange, California, United States
US001 — Orlando, Florida, United States
US003 — Rochester, Minnesota, United States
US005 — Kansas City, Missouri, United States
US0011 — Dallas, Texas, United States
US006 — Dallas, Texas, United States
US004 — Seattle, Washington, United States
MX003 — Guadalajara, Mexico

Full record on ClinicalTrials.gov

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