Phase 3 Epilepsy Trial, Recruiting (NCT07377032)

Phase 3 Epilepsy Trial, Recruiting NCT07377032 Sponsor: Meyer Children's Hospital IRCCS Condition: Epilepsy

Printed from Voxsanity (voxsanity.com.au) — NCT07377032 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Epilepsy

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You or your child has been diagnosed with a GRIN-related neurodevelopmental disorder (GRIN-NDD)
You or your child has a specific type of genetic change (called a loss-of-function variant) in one of these genes: GRIN1, GRIN2A, GRIN2B, or GRIN2D
A parent, caregiver, or legal guardian has been fully informed about the study and has agreed to take part by signing a consent form
If the participant is able to understand and agree themselves, they have also signed a consent or agreement form, following local rules and based on their ability to understand
The parent(s) or caregiver(s) are willing and able to attend study visits and follow the study procedures
If the participant has previously taken L-serine supplements, they are willing to stop taking them for at least one week before the study begins

Who may not be able to join:

The participant is younger than 2 years old at the time of screening
The participant has a known allergy or intolerance to L-serine, the placebo, or any ingredients used in the study treatments
The participant has another serious or unstable health condition (other than epilepsy) that the study doctor believes could put them at risk or affect their ability to take part
The participant has any other significant illness or condition that could affect their safety, the study results, or their ability to complete the study
The parent(s) or caregiver(s) are not able to provide adequate supervision, as judged by the study doctor
The participant has taken part in another clinical trial using an experimental medicine within the past 6 months
The participant is pregnant or breastfeeding
The genetic change found in the participant's GRIN gene cannot be clearly confirmed to affect gene function in the specific way required for this study (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 23 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 00390555662719

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07377032

Sponsor: Meyer Children's Hospital IRCCS

Phase: Phase 3

Status: Recruiting

Condition: Epilepsy

Trial contact: 00390555662719

More information: https://clinicaltrials.gov/study/NCT07377032

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You or your child has been diagnosed with a GRIN-related neurodevelopmental disorder (GRIN-NDD)
You or your child has a specific type of genetic change (called a loss-of-function variant) in one of these genes: GRIN1, GRIN2A, GRIN2B, or GRIN2D
A parent, caregiver, or legal guardian has been fully informed about the study and has agreed to take part by signing a consent form
If the participant is able to understand and agree themselves, they have also signed a consent or agreement form, following local rules and based on their ability to understand
The parent(s) or caregiver(s) are willing and able to attend study visits and follow the study procedures
If the participant has previously taken L-serine supplements, they are willing to stop taking them for at least one week before the study begins

Who may not be able to join:

The participant is younger than 2 years old at the time of screening
The participant has a known allergy or intolerance to L-serine, the placebo, or any ingredients used in the study treatments
The participant has another serious or unstable health condition (other than epilepsy) that the study doctor believes could put them at risk or affect their ability to take part
The participant has any other significant illness or condition that could affect their safety, the study results, or their ability to complete the study
The parent(s) or caregiver(s) are not able to provide adequate supervision, as judged by the study doctor
The participant has taken part in another clinical trial using an experimental medicine within the past 6 months
The participant is pregnant or breastfeeding
The genetic change found in the participant's GRIN gene cannot be clearly confirmed to affect gene function in the specific way required for this study (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 23 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 3

Sponsor

Meyer Children's Hospital IRCCS

Registry

ClinicalTrials.gov

Start date

29 August 2025

Est. completion

1 June 2028

Where this trial is recruiting

🇫🇷 France 🇮🇹 Italy 🇵🇱 Poland

Primary endpoints

Change in Clinical Global Impression - Severity (CGI-S) score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov