
    the study was terminated due to recruitment challenges
  
['dravet syndrome']
['clobazam']

        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.
      