---
title: Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
nct_id: NCT01983722
overall_status: APPROVED_FOR_MARKETING
sponsor: "Children's Hospital Medical Center, Cincinnati"
study_type: EXPANDED_ACCESS
primary_condition: Dravet Syndrome
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01983722.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01983722"
ct_last_update_post_date: 2026-01-23
last_seen_at: "2026-05-12T06:23:01.513Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

**NCT ID:** [NCT01983722](https://clinicaltrials.gov/study/NCT01983722)

## Key Facts

- **Status:** APPROVED_FOR_MARKETING
- **Study Type:** EXPANDED_ACCESS
- **Lead Sponsor:** Children's Hospital Medical Center, Cincinnati
- **Conditions:** Dravet Syndrome
- **CT.gov Last Update:** 2026-01-23

## 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.

## Eligibility

- **Minimum age:** 6 Months
- **Sex:** ALL

```
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
```

## Interventions

- **Stiripentol** (DRUG)

## Locations (1)

- Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cincinnati children's hospital medical center|cincinnati|ohio|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01983722.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01983722*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*