Treatment Plan to Provide Expanded Access to Stiripentol... | NCT01983722

Studies
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

NCT01983722

Sponsor

Children's Hospital Medical Center, Cincinnati

Status

Approved for marketing

Last Update Posted

Jan 23, 2026Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Dravet Syndrome

Interventions

Stiripentol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Approved for marketing

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 7, 2013

First Submission Date that Met QC Criteria

Nov 7, 2013

First Posted Date

Nov 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2026

Last Update Posted Date

Jan 23, 2026Actual

Description Module

Brief Summary

Expanded access to Stiripentol for patients with Dravet Syndrome.

Detailed Description

This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Individual Patients

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Stiripentol	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6 months and older
Diagnosis of Dravet Syndrome with intractable seizures

Exclusion Criteria:

Hypersensitivity to the active substance or to any of the excipients
Past history of psychoses in the form of episodes of delirium
Impaired hepatic and/or renal function, defined as creatinine >2 and/or transaminase >4xULN

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45229	United States

Condition Browse Module

MeSH Terms

ID	Term
D004831	Epilepsies, Myoclonic

Ancestor Terms

ID	Term
D004829	Epilepsy, Generalized
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided