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Honeycomb: Evaluation of Radiprodil in Children with GRIN-related Disorder

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 14 to 15
    v7
  2. Primary and study completion dates: Nov 2025 to Nov 2026
    • Study sites: 13 to 14
    v6
  3. Site contacts updated at 1 of 13 sites
    • Study title expanded, about 1 word
    v5
  4. Primary and study completion dates: Nov 2023 to Nov 2025
    • Study sites: 8 to 13
    • Secondary endpoints: details revised at 10 of 10 entries
    • Study description expanded, about 144 words
    v4
  5. Study sites: 7 to 8v3
  6. Study sites: 4 to 7v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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-101 is a phase 1B trial to assess safety, tolerability, PK, and potential efficacy of radiprodil for the treatment of GRIN-related disorder in children with a Gain-of-Function (GoF) genetic variant. 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. After the end of part A, all participants who are still eligible can choose to continue to receive radiprodil as part of an open-label long-term treatment period (Part B).
Trial Details
NCT Number NCT05818943
Lead Sponsor GRIN Therapeutics, Inc.
Conditions
(from sponsor)		 GRIN-related Disorders
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov