Clinical Research Directory

Inclusion Criteria: * Age: ≥6 months to ≤12 years, with GRIN gene variants known to result in GoF of the NMDA receptor. * Cohort 1 must have at least 1 observable motor seizure per week and ≥4 observable motor seizures (generalized or focal) during the prospective 4-week Observation Period and must have failed to obtain adequate seizure control with at least 2 antiseizure medications (ASMs) used at appropriate dose and duration. * Cohort 2 must have significant behavioral and/or motor symptoms based on caregiver report with a CGI-S score ≥4. * Stable antiseizure therapies and nonpharmacological treatments such as ketogenic diet throughout screening and study participation. Exclusion Criteria: * Any other clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder unrelated to GRIN-related disorder that would preclude or jeopardize participant's safe participation or the conduct of the study according to the judgement of the investigator. * Clinically significant laboratory or ECG abnormalities. * Severe hepatic dysfunction (Child-Pugh grade C). * History of brain surgery for epilepsy or any other reason. * Receiving treatment with contraindicated concomitant drugs such as agonists or antagonists of the glutamate receptor, including but not limited to felbamate, memantine, and perampanel. * Receiving treatment with hormonal therapy such as adrenocorticotrophic hormone or prednisolone.