NCT01533506

Brief Summary

The patient has failed all other available agents and has intractable epilepsy due to Dravet Syndrome. Stiripentol is highly efficacious in Dravet Syndrome. The overall goals of therapy with Stiripentol are primarily to significantly reduce the frequency and severity of seizures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

February 9, 2012

Last Update Submit

February 26, 2013

Conditions

Dravet Syndrome

Keywords

treatment with stiripentol

Interventions

stiripentolDRUG

Stiripentol up to 30 mg/kg/day to control seizures

Also known as: Diacomit

Eligibility Criteria

Age11 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Genetic diagnosis of Dravet syndrome with intractable seizures despite failing all available medications for seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Epilepsies, Myoclonic

Interventions

stiripentol

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Officials

  • Elaine Wirrell, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)