Clinical Trial

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

Active, Not Recruiting Phase 1/2
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Record status
This record was last updated April 1, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-04-26; most recent amendment 2026-03-27.
Status change: Recruiting → Active, Not Recruiting 2026-03-27
Trial Details
NCT Number NCT06392009
Lead Sponsor GRIN Therapeutics, Inc.
Conditions Tuberous Sclerosis Complex, Focal Cortical Dysplasia
Enrollment 30 participants
Start Date 2024-07-10
Primary Completion 2026-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-01