Suspended

Compassionate Use of Stiripentol in Dravet Syndrome

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What is being tested

Stiripentol

Drug
Who is eligible

Epileptic Syndromes+4

+ Brain Diseases

+ Central Nervous System Diseases

From 1 to 21 Years
See all eligibility criteria
How is it accessible

Suspended

Available upon a request by a licensed MD
Expanded Access
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Last updated: October 4, 2019
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorUniversity of Colorado, Denver
Last updated: October 4, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 21 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Epileptic SyndromesBrain DiseasesCentral Nervous System DiseasesEpilepsyEpilepsy, GeneralizedNervous System DiseasesEpilepsies, Myoclonic

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Children's Hospital Colorado

Aurora, United StatesOpen Children's Hospital Colorado in Google Maps
SuspendedOne Study Center
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