RecruitingPhase 1Phase 2NCT06392009

Astroscape: A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II

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

Sponsor

GRIN Therapeutics, Inc.

Enrollment

30 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Tuberous Sclerosis Complex Focal Cortical Dysplasia

Summary

Study RAD-GRIN-201 is a phase 1B/2A trial to assess safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in participants with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A and one year in Part B/long-term treatment period. The treatment period in Part B may be extended based on a favorable benefit/risk profile.

Eligibility

Min Age: 6 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called radiprodil in children and adults with hard-to-treat seizures caused by either tuberous sclerosis complex (TSC) or focal cortical dysplasia type II (FCD II) — both are brain conditions that cause frequent, often uncontrollable seizures. **You may be eligible if...** - You have a confirmed diagnosis of TSC or FCD type II - You still have seizures despite trying at least 2 different seizure medications - You have had at least 8 countable seizures per month, with seizures occurring in at least 3 of the 4 baseline weeks - Your seizure medications, diet, or stimulation devices have been stable for at least 28 days before the study **You may NOT be eligible if...** - You have severe liver disease - You have had brain surgery within the past 6 months - You have significant abnormalities on heart monitoring (ECG) - You have another unrelated neurological or psychiatric condition that could complicate the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRadiprodil

Radiprodil is an orally active, negative allosteric modulator of the NR2B subunit of the NMDA receptor.

Locations(20)

Centrum Medyczne Plejady

Krakow, Poland

The Hospital for Sick Children (Sick Kids)

Toronto, Canada

Queensland Children Hospital

South Brisbane, Australia

Universitair Ziekenhuis Antwerpen (UZA)

Antwerp, Belgium

University Hospitals Leuven, Pediatric Neurology

Leuven, Belgium

BC Children's Hospital

Vancouver, Canada

IRCCS Istituto Giannina Gaslini

Genoa, Liguria, Italy

Instytut Pomnik - Centrum Zdrowia Dziecka

Warsaw, Poland

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)

Roma, Italy

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

Roma, Italy

UMC Uthrecht - Wilhelmina Kinderziekenhuis

Utrecht, Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

Hospital Universitario Vall D´Hebrón

Barcelona, Spain

Hospital Materno Infantil Sant Joan de Deu de Barcelona

Barcelona, Spain

Hospital Universitario Vithas La Milagrosa

Madrid, Spain

AOU Meyer

Florence, Tuscany, Italy

Alberta Children's Hospital

Calgary, Canada

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

Bristol, United Kingdom

Hospital Ruber Internacional

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06392009

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