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New hope for dravet syndrome: expanded access to seizure drug stiripentol

NCT ID NCT01983722

Disease control Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved This study
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This program provides expanded access to the drug stiripentol for people aged 6 months and older with Dravet syndrome, a severe form of epilepsy. The goal is to help control seizures that do not respond to other treatments. Participants must have a confirmed diagnosis and meet safety criteria, such as no severe liver or kidney problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stiripentol
What this could lead to
If successful, this program could offer a treatment option to reduce seizures in patients with Dravet syndrome who have not responded to other therapies.
What could go wrong
This is an expanded access program, not a formal trial, so evidence on effectiveness and safety is limited. Stiripentol may cause side effects like drowsiness or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Epilepsies, Myoclonic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dravet syndrome

Contacts and locations

Locations

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.