Study with Radiprodil in Children with GRIN-related Disorder
Research type
Research Study
Full title
A Multinational, Multicenter Study With an Open-Label Phase 1b and a Randomized, Double-Blind, Placebo-Controlled Phase 3 Followed by an Open-Label Extension to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Radiprodil in Participants With GRIN-Related Neurodevelopmental Disorder
IRAS ID
1008506
Contact name
Michael Panzara
Contact email
Sponsor organisation
GRIN Therapeutics, Inc.
Eudract number
2022-000317-14
Clinicaltrials.gov Identifier
Research summary
This is an open-label, multicenter, phase 1b study in pediatric participants with GRIN related disorders. The participants will be split into 1 of 2 groups: participants with drug-resistant seizures (with or without behavioral symptoms) or participants with behavioral symptoms (but no qualifying seizures). The study will consist of 2 parts; a dose escalation part (Part A) to determine the safety, tolerability, and pharmacokinetics of different doses of radiprodil, and a long-term follow-up period (Part B) to assess the treatment effect on seizures and behavioral symptoms. \nThe study aims to find a safe and well tolerated dose after approximately 8 weeks of continuous treatment during Part A. Initial signs of efficacy and changes in quality of life will also be evaluated. \nThe study will further evaluate the long-term safety and tolerability of radiprodil and assess the maintenance of the treatment effect during Part B.\nThis study will enroll approximately 24 participants in the EU, UK and North America.
REC name
West of Scotland REC 1
REC reference
23/WS/0143
Date of REC Opinion
14 Nov 2023
REC opinion
Further Information Favourable Opinion