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Can a new drug tame seizures in two severe epilepsy syndromes?

NCT ID NCT06422377

Disease control Sponsor: Takeda 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 Results may not be published yet.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 This study
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
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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This phase 3 trial tests whether soticlestat can reduce seizures in people with Dravet syndrome or Lennox-Gastaut syndrome who have already used fenfluramine. Participants take soticlestat as tablets or mini-tablets, and researchers measure changes in seizure frequency over the first 12 weeks of maintenance. The study is open-label, meaning everyone knows they are receiving the drug, and it aims to see if soticlestat offers a safe and effective additional option for these hard-to-treat epilepsy conditions.

What this could mean

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

Active substance
soticlestat (also known as TAK-935), taken as tablets or mini-tablets
What this could lead to
If it works, soticlestat could offer another treatment option to reduce seizures in people with Dravet or Lennox-Gastaut syndrome who have already tried fenfluramine.
What could go wrong
This is a small, open-label study without a placebo, so results may be less reliable. Soticlestat may not reduce seizures enough, and it could cause side effects.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1 person

The number who actually took part.

Started

Apr 2024

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

2 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. The participant has been exposed to fenfluramine (currently on or used previously). 2. The participant has a clinical diagnosis of LGS and a history of, on average, ≥12 MMD seizures in the last 90 days immediately before screening based on historical information, and the participant has ≥4 MMD seizures during a minimum of 4 weeks of seizure data collection during the prospective baseline period. 3. The participant is currently taking 0 to 5 antiseizure treatments (eg. antiseizure medications \[ASMs\], vagus nerve stimulation \[VNS\], ketogenic diet) at stable doses. Exclusion Criteria: 1. The participant is currently enrolled in a clinical study involving an investigational product or treatment device (ie, not approved in that country, other than soticlestat), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Note: Compatibility will be determined on the basis of consultation with the sponsor/designee. 2. The participant has a known hypersensitivity to any component of the soticlestat formulation. 3. Participants aged ≥6 years who have positive answers on item numbers 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) before dosing are excluded. This scale will only be administered to participants aged ≥6 years at the time of enrollment or participants who turn 6 after enrollment.

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Epilepsies, Myoclonic Lennox-Gastaut syndrome

As listed by the trial registrant

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

Dravet syndrome (DS) Lennox-Gastaut syndrome (LGS)

Contacts and locations

Locations

  • Epilepsihospitalet Filadelfia

    Dianalund, Region Sjælland, 4293, Denmark

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