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

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.

The inclusion and exclusion criteria for the patients who participated in lead-in Study 14362A will be transferred from the 14362A study and for the patients who did not participate in lead-in Study 14362A the inclusion/exclusion is separately listed below.

Inclusion Criteria:

1. The patient has a diagnosis of Dravet Syndrome supported by:

   1. onset of seizures in the first year of life

   2. history of fever-induced prolonged seizures as determined by the Investigator

      • these may include prolonged (approximately 15 minutes or longer) hemi-clonic seizures

   3. multiple seizure types which may include:

      • generalised tonic-clonic (required for inclusion)
      • clonic (required for inclusion)
      • myoclonic jerks/seizures

   4. history of normal development prior to seizure onset followed by development delay or regression after seizure onset

   5. abnormal EEG consistent with Dravet Syndrome

2. 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.