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New drug radiprodil tested for tough seizures in two brain conditions

NCT ID NCT06392009

Disease control Sponsor: GRIN Therapeutics, Inc. 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 early-phase trial tests an experimental drug called radiprodil in 30 people with tuberous sclerosis complex or focal cortical dysplasia type II whose seizures have not responded to at least two other medications. The study is open-label, meaning everyone gets the drug, and will check safety, how the body processes the drug, and whether it reduces seizures and behavioral symptoms over up to one year.

What this could mean

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

Active substance
radiprodil
What this could lead to
If it works, this could point toward a new treatment option for hard-to-control seizures in people with TSC or FCD type II.
What could go wrong
This is an early, small, open-label study with no placebo group, so results may not prove effectiveness. Side effects are still being identified.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

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

6 months to 18 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: * Failed to respond to at least 2 anti-seizure medications (ASMs) at appropriate dosages and duration * Disease specific criteria: 1. diagnosis of FCD Type II based on clinical symptoms and confirmed by a positive magnetic resonance imaging (MRI) 2. diagnosis of TSC by either clinical or genetic diagnostic criteria (Northrup, 2021) as documented in the participant's medical record - Participant on average has had at least 8 countable/witnessed primary seizures during a 4-week baseline period with at least 1 seizure occurring in at least 3 of the 4 weeks of baseline * All medical interventions for epilepsy / behavior (including ketogenic diet and any neurostimulation devices) should be stable for 28 days prior to screening with no more than 6 days per month use of rescue medication. Participants must remain on a stable regimen throughout the treatment period * Participant has had an MRI scan within 12 months of the planned date of first dose of study drug Exclusion Criteria: * Any other clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder unrelated to TSC or FCD Type II that would preclude or jeopardize participant's safe participation or administration of study drug or the conduct of the study according to the judgement of the investigator. * Clinically significant laboratory or ECG abnormalities. * Severe hepatic dysfunction (Child-Pugh grade C). * History of brain surgery within 6 months of screening for epilepsy or any other reason. * Contraindications to radiprodil or with known hypersensitivity to the active substance or the excipients or other chemically closely related substances. * Receiving treatment with contraindicated concomitant drugs such as agonists or antagonists of the glutamate receptor, including but not limited to felbamate, memantine, and perampanel. * body weight \<10kg for whom a gastric tube is the only possibility for radiprodil dosing.

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Conditions

The condition(s) this trial relates to.

Focal Cortical Dysplasia isolated focal cortical dysplasia isolated focal cortical dysplasia type II tuberous sclerosis tuberous sclerosis 1

As listed by the trial registrant

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

Focal cortical dysplasia Tuberous sclerosis complex

Contacts and locations

Locations

  • AOU Meyer

    Florence, Tuscany, 50139, Italy

  • Alberta Children's Hospital

    Calgary, T3A 2X6, Canada

  • Centrum Medyczne Plejady

    Krakow, 30363, Poland

  • Hospital Materno Infantil Sant Joan de Deu de Barcelona

    Barcelona, 08950, Spain

  • Hospital Ruber Internacional

    Madrid, 28034, Spain

  • Hospital Universitario Vall D´Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitario Vithas La Milagrosa

    Madrid, 28010, Spain

  • IRCCS Istituto Giannina Gaslini

    Genoa, Liguria, 16146, Italy

  • Instytut Pomnik - Centrum Zdrowia Dziecka

    Warsaw, 04730, Poland

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)

    Roma, 00165, Italy

  • Queensland Children Hospital

    South Brisbane, 4101, Australia

  • The Hospital for Sick Children (Sick Kids)

    Toronto, M5G 1X8, Canada

  • UMC Uthrecht - Wilhelmina Kinderziekenhuis

    Utrecht, 3508, Netherlands

  • Universita Cattolica del Sacro Cuore - Policlinico Universitario "Agostino Gemelli"

    Roma, 00168, Italy

  • University Hospitals Bristol and Weston NHS Foundation Trust Bristol Royal Hospital for Children

    Bristol, BS2 8BJ, United Kingdom

  • University Hospitals Leuven, Pediatric Neurology

    Leuven, 3000, Belgium

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60356, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80952, Poland

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