Status:
NO_LONGER_AVAILABLE
Compassionate Use of Stiripentol in Dravet Syndrome
Lead Sponsor:
University of Colorado, Denver
Conditions:
Dravet Syndrome
Eligibility:
All Genders
1-21 years
Brief Summary
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 predomina...
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01835314
Last Update
October 4 2019
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045