Compassionate Use of Stiripentol in Dravet Syndrome

N/ANo Longer AvailableNCT01835314

University of Colorado, Denver

Overview

Compassionate use of Stiripentol in Dravet Syndrome. This is a treatment protocol, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

This is a treatment protocol for compassionate use, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

Study Type

EXPANDED_ACCESS

Conditions

Dravet Syndrome

Interventions

StiripentolDRUG

Stiripentol 5-50mg/kg/d divided twice or three times a day by mouth

Eligibility

Sex: ALLMin age: 1 YearMax age: 21 Years

Medical Language ↔ Plain English

Children with genetic confirmation of Dravet syndrome (a documented sodium channel, voltage-gated, type I, alpha subunit (SCN1A) mutation) or clinical confirmation of Dravet syndrome by two pediatric neurologist will be considered to have Dravet syndrome. In order to enter the treatment protocol there will be documented treatment failure of at least two therapeutic anticonvulsants excluding Na channel blockers. Anticonvulsants that are Na channel blockers such as carbamazepine and lamotrigine as known to provoke seizures in this patient population.

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Data from ClinicalTrials.gov

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