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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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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.

Record History

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  1. Primary completion date: Jul 2025 to Jun 2026v5 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 20 to 18
    • Study completion date: Jul 2026 to Jun 2028
    • Study description revised
    • Eligibility criteria expanded, about 1 word
  2. Site details revised at 20 of 20 sitesv4
  3. Eligibility criteria expanded, about 18 words
    • Site details revised at 20 of 20 sites
    v3
  4. Start date changed from estimate of May 2024 to Jul 10, 2024
    • Study sites revised (20)
    • Study title expanded, about 1 word
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06392009
Lead Sponsor GRIN Therapeutics, Inc.
Conditions
(from sponsor)		 Tuberous Sclerosis Complex, Focal Cortical Dysplasia
Related terms Focal Cortical Dysplasia, Tuberous Sclerosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov