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NCT05818943 · ClinicalTrials.gov registry record · Phase 1
Honeycomb: Evaluation of Radiprodil in Children with GRIN-related Disorder
A Phase 1 study of GRIN-related Disorders, sponsored by GRIN Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 15
- Study locations
NCT05818943: Active Phase 1 study of GRIN-related Disorders, sponsored by GRIN Therapeutics.
NCT05818943 is a Phase 1 study of GRIN-related Disorders that is active but no longer recruiting, run by GRIN Therapeutics. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 15 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05818943, a Phase 1 study of GRIN-related Disorders, is active but no longer recruiting, sponsored by GRIN Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 15
- Study locations
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).
Primary Outcome
Frequency, type, severity and duration of adverse events, serious adverse events and adverse drug reactions.
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-03-07 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
What the registry record for NCT05818943 still lists
NCT05818943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
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.
NCT05818943 lists 15 locations in 7 states (Other, Maryland, New York).
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.
What interventions are being tested in trial NCT05818943?
The interventions under investigation include: Radiprodil (DRUG).
Who is sponsoring clinical trial NCT05818943?
This trial is sponsored by GRIN Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05818943's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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