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

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 developmentdelay or regression after seizure onset

• abnormal EEG consistent with Dravet Syndrome 2. The patient has a history ofapproximately 2 tonic-clonic or clonic seizures in 2 weeks 3. The patient istreated with at least 1 but no more than 3 antiepileptic drugs (AEDs) [VagalNerve 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 takenthese 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, andrufinamide. If patients have taken these drugs in the past, they need to have been offdrug for 5 half-lives

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

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

5. The patient has received clobazam within 3 months prior to the Screening Visit. If thepatient has received clobazam in the past, discontinuation must not have been foradverse events or lack of efficacy Other protocol-defined inclusion and exclusion criteria may apply.