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Compassionate Use of Stiripentol in Dravet Syndrome

Compassionate Use of Stiripentol in Dravet Syndrome

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01835314
Enrollment
Unknown
Registered
2013-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2019-10-04

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

Conditions

Dravet Syndrome

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 predominantly by parent and caregiver report.

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 report.

Interventions

DRUGStiripentol

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

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
1 Years to 21 Years

Inclusion criteria

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.

Countries

United States

Outcome results

None listed

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