Honeycomb: Evaluation of Radiprodil in Children with GRIN-related Disorder (NCT05818943)
A Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms of Multiple Individually Titrated Doses of Radiprodil in Children with GRIN-related Disorder
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland
Age range: 6 Months to 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland
- Columbia University Irving Medical Center, Dept of Neurology — New York, New York
- Queensland Children's Hospital — South Brisbane, Queensland
- The Hospital for Sick Children (Sick Kids) — Toronto, Ontario
- BC Children's Hospital — Vancouver,
- Abteilung für Neuropädiatrie, Klinik und Poliklinik für Kinder - und Jugendmedizin, Universitätsklinikum Leipzig — Leipzig,
- KBO-Kinderzentrum München gemeinnützige GmbH — München,
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale Pediatrico Bambino Gesu — Rome, Lazio
- Azienda Ospedaliero Universitaria Careggi (AOUC) Firenze - Azienda Ospedaliera Universitaria Meyer — Florence, Tuscany
- 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,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All GRIN-related Disorders clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.