Dravet SyndromeNCT01983722
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
A study testing Stiripentol in people with Dravet Syndrome, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Expanded access to Stiripentol for patients with Dravet Syndrome. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Dravet Syndrome
- What is being tested?
- Stiripentol
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 6 months and older
- Diagnosis of Dravet Syndrome with intractable seizures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Expanded access to Stiripentol for patients with Dravet Syndrome.
Read the detailed description
This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.
- Conditions
- Dravet Syndrome
- Being tested
- Stiripentol
- Medical subject headings
- Epilepsies, Myoclonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StiripentolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dravet SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983722
- Sponsor's protocol ID
- 2013-5518
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2013
- Last updated
- 23 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
- ClinicalTrials.gov ID
- NCT01983722
- Acronym / sponsor ID
- 2013-5518
- Conditions
- Dravet Syndrome
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 6 months and older
- Diagnosis of Dravet Syndrome with intractable seizures
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stiripentol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stiripentol in people with Dravet Syndrome, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.