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

Last updated: June 30, 2025
Sponsor: GRIN Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Scar Tissue

Precancerous Condition

Neurofibromatosis

Treatment

Radiprodil

Clinical Study ID

NCT06392009
RAD-GRIN-201
2023-506301-20-00
  • Ages 6-18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Failed to respond to at least 2 anti-seizure medications (ASMs) at appropriatedosages and duration.

  • Disease specific criteria:

  1. diagnosis of FCD Type II based on clinical symptoms and confirmed by a positivemagnetic resonance imaging (MRI)

  2. diagnosis of TSC by either clinical or genetic diagnostic criteria (Northrup,

  1. as documented in the participant's medical record.

  • Participant on average has had at least 8 countable/witnessed primary seizuresduring a 4-week baseline period with at least 1 seizure occurring in at least 3 ofthe 4 weeks of baseline

  • All medical interventions for epilepsy / behavior (including ketogenic diet and anyneurostimulation devices) should be stable for 28 days prior to screening with nomore than 6 days per month use of rescue medication. Participants must remain on astable regimen throughout the treatment period.

  • Participant has had an MRI scan within 12 months of the planned date of first doseof study drug.

Exclusion

Exclusion Criteria:

  • Any other clinically relevant medical, neurologic, or psychiatric condition and/orbehavioral disorder unrelated to TSC or FCD Type II that would preclude orjeopardize participant's safe participation or administration of study drug or theconduct 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 otherreason.

  • Contraindications to radiprodil or with known hypersensitivity to the activesubstance or the excipients or other chemically closely related substances.

  • Receiving treatment with contraindicated concomitant drugs such as agonists orantagonists 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 radiprodildosing.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Radiprodil
Phase: 1/2
Study Start date:
July 10, 2024
Estimated Completion Date:
July 31, 2026

Study Description

Approximately 20 participants with TSC and 10 participants with FCD type II will be enrolled.

The effects of radiprodil are assessed in participants with treatment-resistant seizures (with or without behavioral symptoms). The daily doses of radiprodil will be individually titrated for every participant and all the participants will receive study drug.

This study is divided into the following periods:

PART A:

  • Screening/Observation Period (up to six(6) weeks): Investigators assess eligibility followed by an Observation Period (at least four(4) weeks) to evaluate seizure frequency.

  • Titration Period (approx. four(4) weeks): Radiprodil twice daily will be administered in escalating doses and plasma concentrations, safety, and tolerability assessed. Once a safe and potentially effective dose has been established, the participant will immediately enter the Maintenance Period.

  • Maintenance Period (approx. twelve(12) weeks): The participant will continue to take the safe and potentially effective dose identified during the Titration Period. At the end of the Maintenance Period the participant will either be invited to enter Part B or the Tapering and Safety Follow-up Period.

  • Tapering (15 days) and Safety Follow-up Period (14 days): a participant who doesn't take part in the long-term treatment period (Part B) will taper (ie gradually decrease) the study medicine for 15 days and enter a safety Follow-up Period (14 days). In this case, the participant will have one (1) last visit at the end of the safety Follow-up Period.

PART B:

  • Long-Term Treatment Period (one(1) year): During the Long-Term Treatment Period (Part B), participants will continue taking radiprodil at the usual dose level and making regular visits to the study site.

  • Tapering (15 days) and Safety Follow-up Period (14 days): at the end of the long-term treatment period (Part B), the participant will taper (ie gradually decrease) the study medicine for 15 days and enter a safety Follow-up Period (14 days) after his/her last dose of radiprodil. The participant will have one (1) last visit at the end of the safety Follow-up Period.

Connect with a study center

  • Queensland Children Hospital

    South Brisbane, 4101
    Australia

    Active - Recruiting

  • Universitair Ziekenhuis Antwerpen (UZA)

    Antwerp, 2650
    Belgium

    Active - Recruiting

  • University Hospitals Leuven, Pediatric Neurology

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Alberta Children's Hospital

    Calgary, T3A 2X6
    Canada

    Active - Recruiting

  • The Hospital for Sick Children (Sick Kids)

    Toronto, M5G 1X8
    Canada

    Active - Recruiting

  • BC Children's Hospital

    Vancouver, BC V6H 3N1
    Canada

    Active - Recruiting

  • IRCCS Istituto Giannina Gaslini

    Genoa, Liguria 16146
    Italy

    Active - Recruiting

  • AOU Meyer

    Florence, Toscana 50139
    Italy

    Active - Recruiting

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

    Roma, 00165
    Italy

    Active - Recruiting

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

    Roma, 00168
    Italy

    Active - Recruiting

  • UMC Uthrecht - Wilhelmina Kinderziekenhuis

    Utrecht, 3508
    Netherlands

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdańsk, 80952
    Poland

    Active - Recruiting

  • Centrum Medyczne Plejady

    Kraków, 30363
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60356
    Poland

    Active - Recruiting

  • Instytut Pomnik - Centrum Zdrowia Dziecka

    Warszawa, 04730
    Poland

    Active - Recruiting

  • Hospital Materno Infantil Sant Joan de Deu de Barcelona

    Barcelona, 08950
    Spain

    Active - Recruiting

  • Hospital Universitario Vall D´Hebrón

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Ruber Internacional

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hospital Universitario Vithas La Milagrosa

    Madrid, 28010
    Spain

    Active - Recruiting

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

    Bristol, BS2 8BJ
    United Kingdom

    Active - Recruiting

  • Royal Hospital for Children

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

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