Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

Expanded access to Stiripentol for patients with Dravet Syndrome.

This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.

Inclusion Criteria:

• 6 months and older
• Diagnosis of Dravet Syndrome with intractable seizures

Exclusion Criteria:

• Hypersensitivity to the active substance or to any of the excipients
• Past history of psychoses in the form of episodes of delirium
• Impaired hepatic and/or renal function, defined as creatinine >2 and/or transaminase >4xULN