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NCT01835314 Clinical Trial

Compassionate Use of Stiripentol in Dravet Syndrome

Dravet Syndrome Clinical Trial

Official title:
Compassionate Use of Stiripentol in Dravet Syndrome

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01835314
Other study ID # 12-0315
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date October 2019
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 1 Year to 21 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Children's Hospital Colorado Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

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