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

Cincinnati Children's Hospital Medical Center

Status

Conditions: Dravet Syndrome

Treatments: Drug: Stiripentol

Study type: Expanded Access

Funder types: Other

Identifiers

NCT01983722

2013-5518

Details and patient eligibility

About

Expanded access to Stiripentol for patients with Dravet Syndrome.

Full description

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

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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