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


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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, oxcarbazepine, lamotrigine, lacosamide, and rufinamide. If patients have taken these drugs in the past, they need to have been off drug for 5 halflives
  3. The patient must not have been on any benzodiazepine chronically (≥2 weeks for any indication) except clobazam for a period of at least 5 half-lives prior to screening
  4. The patient is on cannabidiol, medical marijuana, or any drug that contains cannabinoids
  5. The patient is currently taking long-term systemic steroids (>2 weeks)

Other protocol-defined inclusion and exclusion criteria may apply.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Elaine Wirrell, M.D.

Closed for enrollment

More information


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