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

NCT05818943 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-11-15

No results posted yet for this study

Summary

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).

Conditions

  • GRIN-related Disorders

Interventions

DRUG

Radiprodil

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

Sponsors & Collaborators

  • GRIN Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Vijay Rai, PhD · Associate Director of Clinical Operations

  • Michael Panzara, MD, MPH · Chief Medical Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818943 on ClinicalTrials.gov