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

        Inclusion Criteria:

          -  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 2. The patient has a history of
                  approximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient is
                  treated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [Vagal
                  Nerve Stimulator (VNS) and ketogenic diet will not be considered an AED] 4.
                  Patient has at least 2 seizures during the Baseline Period of either 2 or 4 weeks

        Exclusion Criteria:

          1. The patient is taking stiripentol, verapamil, or felbatol. If patients have taken
             these drugs in the past, they need to have been off drug for 5 half-lives

          2. The patient is taking a sodium channel blocker including, but not limited to,
             phenytoin, fosphenytoin, carbamazepine, oxcarbamazepine, lamotrigine, lacosamide, and
             rufinamide. If patients have taken these drugs in the past, they need to have been off
             drug for 5 half-lives

          3. The patient is on cannabidiol, medical marijuana, or any drug that contains
             cannabinoids

          4. The patient has received chronic treatment (≥2 weeks for any indication) with a
             benzodiazepine within at least 5 half-lives prior to screening. Rescue therapy for
             prolonged seizures is allowed

          5. The patient has received clobazam within 3 months prior to the Screening Visit. If the
             patient has received clobazam in the past, discontinuation must not have been for
             adverse events or lack of efficacy

        Other protocol-defined inclusion and exclusion criteria may apply.
      