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NMDA Receptor Antagonist

Radiprodil for GRIN Disorders

Phase 1
Recruiting
Research Sponsored by GRIN Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 5) to study completion (average of 2 years).
Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of radiprodil for treating a specific genetic disorder in children. All participants will receive radiprodil in the initial phase of the study lasting up

Who is the study for?
This trial is for children aged 6 months to 12 years with GRIN gene variants causing overactive NMDA receptors. Participants must have frequent motor seizures or significant behavioral/motor symptoms despite previous treatments. They should be on stable seizure therapies during the study.Check my eligibility
What is being tested?
The trial tests Radiprodil's safety, tolerability, and potential effectiveness in treating GRIN-related disorders in kids. It's an open-label phase 1B study where all participants receive the drug, first in a six-month period (Part A), then possibly longer-term (Part B).See study design
What are the potential side effects?
As this is a phase 1B trial primarily assessing safety and tolerability, specific side effects of Radiprodil are not detailed here but may include typical drug reactions such as nausea, fatigue, allergic responses or other unforeseen issues related to its mechanism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 5) to study completion (average of 2 years).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 5) to study completion (average of 2 years). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), TEAEs Leading to Discontinuation and Severity of TEAEs
Maximum Plasma concentration of radiprodil (Cmax)
Pharmacokinetic plasma concentration of radiprodil, Time corresponding to occurrence of Cmax (Tmax)
+3 more
Secondary outcome measures
Aberrant Behavior Checklist-Community (ABC-C)
Caregiver Burden Inventory (CBI)
Caregiver Global Impression of Change (CaGI-C)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RadiprodilExperimental Treatment1 Intervention
Liquid suspension of radiprodil, at concentrations 0.25 mg/mL or 2.50 mg/mL for 1% and 10% formulation respectively. It will be administered twice a day (bid) either orally or via gastric or nasogastric tube, slowly up-titrated to the highest tolerated dose.

Find a Location

Who is running the clinical trial?

GRIN Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Vijay Rai, PhDStudy DirectorAssociate Director of Clinical Operations
Michael Panzara, MD, MPHStudy ChairChief Medical Officer
3 Previous Clinical Trials
3,715 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of thirty eligible to enroll in this trial?

"This clinical investigation is open to participants aged over 6 months but under 12 years."

Answered by AI

At how many different venues is this medical investigation currently accessible?

"Patients can enroll at various medical centers such as BC Children's Hospital in Vancouver, Ontario; Queensland Children's Hospital in South Brisbane; Lazio; The Hospital for Sick Children (Sick Kids) in Toronto, Toscana. Additionally, there are 13 other locations where patients may also participate."

Answered by AI

What is the current number of individuals eligible for enrollment in this clinical research study?

"Indeed, the details on clinicaltrials.gov affirm that patient recruitment is ongoing for this trial. Originally shared on March 7th, 2023, and last modified on April 15th, 2024, the study aims to enroll a total of 24 participants distributed among thirteen different locations."

Answered by AI

What are the specific goals and objectives of this research study?

"The primary goal of this examination, to be evaluated during specific time points such as Titration Visit 1 at week 5 and various other visits up to Maintenance Visit 4 at week 20, is to assess the occurrence of Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (SAEs), TEAEs Leading to Discontinuation, and the intensity of these adverse events. Additional aims encompass evaluating Clinical Global Impression of Change [CGI-C], Pediatric Quality of Life Inventory [PedsQL], and Caregiver Global Impression of Change (CaGI-C) as secondary endpoints."

Answered by AI

What is the safety profile of Radiprodil for human use?

"Radiprodil's safety rating is 1 according to our team at Power, as this trial falls under Phase 1 with minimal existing data on both its efficacy and safety."

Answered by AI

Are there any ongoing opportunities for patients to participate in this medical study?

"As indicated on clinicaltrials.gov, the current focus is on identifying suitable participants for this research endeavor. The study was initially shared with the public on March 7th, 2023 and received its latest update on April 15th, 2024."

Answered by AI

Is it possible for individuals to participate in this clinical trial?

"- Cohort 2 individuals should exhibit significant behavioral and/or motor symptoms as reported by caregivers, with a Clinical Global Impression–Severity (CGI-S) score of ≥4."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Radiprodil in Children With GRIN-related Disorder
2023. "Evaluation of Radiprodil in Children With GRIN-related Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05818943.
~13 spots leftby Nov 2025
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