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The Honeycomb Study

The Honeycomb Study is investigating a investigational radiprodil in children who have GRIN-related Disorder. This initial study will only be recruiting patients with GRIN-related Disorder with a gain-of-function (GoF) variant of: GRIN1, GRIN2A, GRIN2B, or GRIN2D. The reason the study is limited to individuals with gain-of-function (GoF) variants is because the investigational radiprodil is designed specifically to decrease the overactive signals being sent out by NMDA receptors caused by gain-of-function (GoF) variants.

To be considered for the Honeycomb Study, your child:

• Must have confirmed gain-of-function (GoF) variant in GRIN1, GRIN2A, GRIN2B, or GRIN2D
• Must be between 6 months and 12 years of age
• For patients with seizures:
  • at least 1 observable seizure per week and 4 or more observable seizures during a 4-week observation period
  • seizures did not improve after taking at least 2 anti-seizure medications
• For patients without qualifying seizures:
  • significant behavioral symptoms

Other eligibility criteria apply. Study participants will receive study-related medical exams and active investigational radiprodil at no cost. If travel is required, a service will help arrange it for you and all reasonable related costs will be covered, to the extent allowable in your country. Children who enroll in this study will be asked to participate for approximately 5 months including both a screening period. During this time, they will be asked to visit the clinic site up to 9 times. Some in-clinic visits may be performed via telephone/home visits for certain patients. Patients may be eligible to investigational radiprodil for extended dosing in the study or they may enter a follow-up period.