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

N/AApproved For MarketingNCT01983722

Children's Hospital Medical Center, Cincinnati

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

Dravet Syndrome

Interventions

StiripentolDRUG

Eligibility

Sex: ALLMin age: 6 Months

Medical Language ↔ Plain English

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

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Data from ClinicalTrials.gov

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