Winter Park, FLNCT07224581Now EnrollingIRB Ready

GRIN-related Neurodevelopmental Disorder Clinical Trial in Winter Park, FL

Access cutting-edge grin-related neurodevelopmental disorder treatment through this clinical trial at a research site in Winter Park. Study-provided care at no cost to qualified participants.

Sponsored by GRIN Therapeutics, Inc.

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Expert Care in Winter Park

Access grin-related neurodevelopmental disorder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related grin-related neurodevelopmental disorder treatment provided free

Apply for This Winter Park Location

Check if you qualify for this grin-related neurodevelopmental disorder clinical trial in Winter Park, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Winter Park

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Winter Park site if eligible
  4. 4Begin participation

About This GRIN-related Neurodevelopmental Disorder Study in Winter Park

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). Participants in each cohort will be randomized 1:1 to receive active drug (radiprodil) or matching placebo (Part A). Following completion of Part A, all eligible participants (including those previously on placebo) may continue into the open-label extension period (Part B) to receive radiprodil. The placebo-controlled portion is expected to be approximately 16 weeks for participants in Phase 3 Cohort 1 and 28 weeks for participants in Phase 3 Cohort 2. The study will evaluate the effect of radiprodil on seizures and non-seizure symptoms and assess safety.

Sponsor: GRIN Therapeutics, Inc.

Who Can Participate

Inclusion 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 according to the judgement of the investigator and sponsor.

Exclusion Criteria

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 administration or the conduct of the study according to the judgement of the investigator or sponsor.
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 preclude or jeopardize participant's safe participation of study drug administration or the conduct of the study according to the judgement of the investigator or sponsor.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Winter Park?

Yes, this clinical trial (NCT07224581) has an active research site in Winter Park, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

GRIN-related Neurodevelopmental Disorder Treatment Options in Winter Park, FL

If you're searching for grin-related neurodevelopmental disorder treatment options in Winter Park, FL, this clinical trial (NCT07224581) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Winter Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced grin-related neurodevelopmental disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all grin-related neurodevelopmental disorder clinical trials near you to find additional studies recruiting in your area.

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