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 (HONEYCOMB)

GRIN-related disorder

Adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) (frequency, type, severity, and duration), Changes in vital signs, Physical examination findings, 12-lead electrocardiogram (ECG) findings, Clinically significant changes in laboratory parameters, Emergence of new seizure types, Occurrence of suicidal ideation or behavior, Plasma concentrations of radiprodil at predefined timepoints

Change from Baseline to end of treatment in seizure frequency from daily seizure electronic diary (eDiary), Percent change from Baseline to end of treatment in video electroencephalogram (V EEG) seizure burden (e.g., seizure type, severity, and frequency recorded during V EEGs), Seizure free days and longest period with no seizures, Change from Baseline to end of treatment in behavioral features as measured by the aberrant behavior checklist-community (ABC C), as well as other disorder features as measured by gross motor function measure (GMFM), sleep disturbance scale for children (SDSC), quality of life (Pediatric Quality of Life Inventory [PedsQL]), Caregiver Burden Inventory (CBI), and global impression (Caregiver Global Impression of Change [CaGI C]), and Clinical Global Impression of Change [CGI-C] scales)

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