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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

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01983722
Enrollment
Unknown
Registered
2013-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dravet Syndrome

Brief summary

Expanded access to Stiripentol for patients with Dravet Syndrome.

Detailed description

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

Interventions

DRUGStiripentol

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026