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Evaluating Radiprodil for Seizures and Behavioral Symptoms in Tuberous Sclerosis and Focal Cortical Dysplasia

A Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Radiprodil in Patients with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) Type II

Phase1; Phase2 Interventional GRIN Therapeutics, Inc. · NCT06392009

This study is testing if a new medication called radiprodil can help people with Tuberous Sclerosis or Focal Cortical Dysplasia who have seizures that don't respond to other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment30 (estimated)
Ages6 Months to 18 Years
SexAll
SponsorGRIN Therapeutics, Inc. Industry-sponsored
Locations20 sites (South Brisbane and 19 other locations)
Trial IDNCT06392009 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety, tolerability, pharmacokinetics, and potential efficacy of radiprodil in patients with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study involves approximately 30 participants who have treatment-resistant seizures, with a structured approach that includes a screening period, a titration period for dose adjustment, and a maintenance phase. Participants will receive radiprodil in escalating doses, and their response will be monitored over a total duration of up to one year. The open-label design ensures all participants receive the treatment, allowing for comprehensive data collection on its effects.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with TSC or FCD type II who have not responded to at least two anti-seizure medications.

Not a fit: Patients who have not experienced treatment-resistant seizures or those who have not had a recent MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce seizure frequency and improve behavioral symptoms in patients with TSC or FCD.

How similar studies have performed: While this approach is novel in its specific application, similar studies targeting treatment-resistant seizures have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

South Brisbane and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Tuberous Sclerosis ComplexFocal Cortical DysplasiaTSCFCDAstroscape
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.