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New treatment option for GRIN-related Neurodevelopmental Disorder
Official title Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder
ClinicalTrials.gov ID: NCT07224581
What this study is testing
What is Radiprodil?
Radiprodil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for grin-related neurodevelopmental disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Phase 3 portion of Study RAD-GRIN-101 is a multinational, multicenter, randomized, double-blind, placebo-controlled trial followed by an open-label extension to evaluate the efficacy and safety of radiprodil in participants with GRIN-related neurodevelopmental disorder (GRIN-NDD) with a gain-of-function (GoF) genetic variant. This study will enroll two cohorts: one cohort of participants with a minimal number of countable motor seizures (with or without behavioral symptoms) (Phase 3 Cohort 1: Qualifying Seizures Cohort); and a second cohort with disease symptoms but no seizures or fewer seizures than required for the Qualifying Seizures Cohort (Phase 3 Cohort 2: Without Qualifying Seizures Auxiliary Cohort).
- Phase 3: a large, late-stage study
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Part A, Participant:
- Diagnosed with GRIN-NDD with GRIN1, GRIN2A, GRIN2B, or GRIN2D gene variants known to result in GoF of the NMDA receptor
- Phase 3 Cohort 1 (Qualifying Seizures Cohort) ONLY: Experiencing at least 1 CMS per week and ≥4 CMS (generalized or focal) during screening
- With history of inadequate response to at least 2 standard antiseizure medications (ASMs)
- Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort) ONLY: With significant neurodevelopmental symptoms and a GRIN-CGI-S score ≥4
You likely can't join if
- PART A, Participant:
- Has clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder (including those related to GRIN-NDD) that would...
- Is receiving \>4 standard ASMs at screening
- Has a body weight of less than 5 kg at screening Part B: \- Participant has clinically relevant medical, neurologic, or psychiatric condition and/or...
See the full eligibility criteria
- Part A, Participant:
- Diagnosed with GRIN-NDD with GRIN1, GRIN2A, GRIN2B, or GRIN2D gene variants known to result in GoF of the NMDA receptor
- Phase 3 Cohort 1 (Qualifying Seizures Cohort) ONLY: Experiencing at least 1 CMS per week and ≥4 CMS (generalized or focal) during screening
- With history of inadequate response to at least 2 standard antiseizure medications (ASMs)
- Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort) ONLY: With significant neurodevelopmental symptoms and a GRIN-CGI-S score ≥4
- On a stable dose of standard ASMs for at least 4 weeks prior to screening and should remain on stable doses throughout study participation
- On stable nonpharmacological treatments such as ketogenic diet and should remain stable throughout study participation Part B: \- Participant has completed Part A and is eligible to continue study participation...
- PART A, Participant:
- Has clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder (including those related to GRIN-NDD) that would preclude or jeopardize participant's safe participation or study drug...
- Is receiving \>4 standard ASMs at screening
- Has a body weight of less than 5 kg at screening Part B: \- Participant has clinically relevant medical, neurologic, or psychiatric condition and/or behavioral disorder (including those related to GRIN-NDD) that would...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Winter Park, Florida, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Brussels, Belgium
- Angers, France
- Bron, France
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Winter Park, Florida, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.