The Beeline Study is a global Phase 3 clinical trial testing radiprodil, an investigational medicine for children with GRIN-related neurodevelopmental disorder (GRIN-NDD) caused by gain-of-function changes in specific GRIN genes. Radiprodil works by targeting the GluN2B part of the NMDA receptor, which can be overactive in these genetic conditions.
This study is for children from 1 month to 18 years old who have confirmed gain-of-function variants in GRIN1, GRIN2A, GRIN2B, or GRIN2D—genes that are important for normal brain development and function.
There are two groups in the study:
- One group with countable motor seizures, and
- One group with significant developmental symptoms but few or no seizures.
Participants are randomly assigned to receive either radiprodil or a placebo during the first part of the study. After that, eligible participants may continue on radiprodil in an open-label extension.
Researchers are studying whether radiprodil is safe and whether it can help improve seizures and other symptoms such as development, behavior, and daily functioning. The study includes measures that were developed with input from families and caregivers to reflect meaningful changes.
At this point in time, the Beeline Study is only enrolling patients in the US. However, later in 2026, the Study will also be enrolling patients in various European counties.
For answers to common questions about the study, eligibility, and how to learn more, see the Beeline Trial FAQ on the GRIN Therapeutics website: https://grintherapeutics.com/resources-for-patients-and-caregivers/#rpcProgOv
Additional information can also be found on: https://clinicaltrials.gov/study/NCT07224581