To participate in this study, the 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 will apply and be discussed at the screening visit.

You and your child will meet with a study coordinator at a study site location closest to you. You will learn more about the research, the trial and the benefits and risks of participation in a trial.

The study coordinator or study doctor will discuss an Informed Consent Form with you and if applicable, your child. Informed Consent involves providing you with adequate information to allow for an informed decision about participation in the Honeycomb Study. The process will provide sufficient opportunity for you to ask questions and to consider whether to participate. This process will occur under circumstances that minimize the possibility of coercion or undue influence. If you are comfortable with the information provided and the answers to your questions, you will be asked to sign the Informed Consent Form allowing you to participate in the Honeycomb Study.

Different procedures and an observational screening period will be performed to see if your child qualifies for the clinical study. You will also be asked questions about your child’s health history.

The Honeycomb Study is studying the 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. The reason the study is limited to individuals with gain-of-function (GoF) variants is because radiprodil was designed to decrease the overactive signals being sent out by NMDA receptors caused by gain-of-function (GoF) GRIN variants.

Your child will be asked to take the investigational radiprodil by mouth or NG- or G-tube, if applicable, twice a day. Parents and caregivers will also be asked to complete an electronic study diary entry at least once day to track their child’s progress throughout the study.

You and your child will visit the study site a total of 9 times over a period of 5 month, Some visits may be performed via telephone or as home visits for certain patients. At these appointments, the study team will ask you questions about your child’s medical health. They will also perform study procedures to evaluate your child’s wellbeing, including physical exams, taking vital signs and blood samples. On two occasions, a video EEG will be performed overnight to record brain signals.

Study centers for the Honeycomb Study can be found globally.

Your child does not have to stop taking medication or change their diet unless they are advised to do so by the study center staff or their primary care physician.

No – there will be no cost to you or loved ones for participating in the Honeycomb Study.

No, health insurance is not a requirement to participate in the Honeycomb clinical trial.

Clinical Research Studies

Clinical trials, also known as clinical studies or research studies are conducted by doctors and researchers to see if new medications or treatments are safe and effective before being approved for use by the general public. For basic information about clinical trials, please visit: https://www.fda.gov/patients/clinical-trials-what-patients-need-know/basics-about-clinical-trials.

Research studies are used to test new medications for safety, tolerability, and effectiveness before they are approved for use by the public.

You can find out more information about clinical trials by browsing through www.clinicaltrials.gov. This is an online, government database that is managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research studies.

All research studies require that doctors and/or researchers give interested participants complete and accurate information about the risks, benefits and activities of a research study. Informed Consent involves providing you and your child with adequate information to allow for an informed decision about participation in the Honeycomb clinical trials. The process will provide sufficient opportunity for you to ask questions and to consider whether to participate. This process will occur under circumstances that minimize the possibility of coercion or undue influence. If you are comfortable with the information provided and the answers to your questions, you will be asked to sign the Informed Consent Form allowing you to participate in the Honeycomb trial.