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ACTIVE NOT RECRUITING Phase 1

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

NCT05818943 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Radiprodil

Study Locations (15)

Other

  • BC Children's Hospital — Vancouver
  • Abteilung für Neuropädiatrie, Klinik und Poliklinik für Kinder - und Jugendmedizin, Universitätsklinikum Leipzig — Leipzig
  • KBO-Kinderzentrum München gemeinnützige GmbH — München
  • ERASMUS Medisch Centrum, Developmental & Genetic pediatrics — Rotterdam
  • UMC Utrecht - Wilhelmina Kinderziekenhuis, Polikliniek Kinderneurologie — Utrecht
  • Universitat de Barcelona - Hospital Sant Joan de Deu Barcelona (HSJDB) — Barcelona
  • Hospital Ruber Internacional — Madrid
  • Royal Hospital for Children Glasgow — Glasgow
  • Great Ormond Street Hospital For Children NHS Foundation Trust — London

Maryland

  • Mid-Atlantic Epilepsy and Sleep Center — Bethesda

New York

  • Columbia University Irving Medical Center, Dept of Neurology — New York

Queensland

  • Queensland Children's Hospital — South Brisbane

Ontario

  • The Hospital for Sick Children (Sick Kids) — Toronto

Lazio

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu — Rome

Tuscany

  • Azienda Ospedaliero Universitaria Careggi (AOUC) Firenze - Azienda Ospedaliera Universitaria Meyer — Florence

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2023-03-07
Est. Completion 2026-11
Phase Phase 1

Sponsor

GRIN Therapeutics

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05818943

The ClinicalTrials.gov registry entry for NCT05818943 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GRIN Therapeutics, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with GRIN-related Disorders appearing as the primary indexed condition, and to 1 intervention — of which Radiprodil is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05818943 reports 15 study locations spanning 7 distinct geographic areas — top geographies include Other, Maryland, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05818943 about?

NCT05818943 is a clinical study titled "Honeycomb: Evaluation of Radiprodil in Children with GRIN-related Disorder". 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. Subject...

What is the current status of trial NCT05818943?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-03-07. Estimated completion is 2026-11.

What conditions does trial NCT05818943 study?

This clinical trial studies the following conditions: GRIN-related Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05818943?

The interventions under investigation include: Radiprodil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05818943?

This trial is sponsored by GRIN Therapeutics, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05818943 being conducted?

This trial has 15 study locations across Maryland, New York, Queensland, Ontario, Lazio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial