Phase 2 Epilepsy Trial, Recruiting (NCT04289467)

Phase 2 Epilepsy Trial, Recruiting NCT04289467 Sponsor: Children's Hospital of Orange County Condition: Epilepsy

Printed from Voxsanity (voxsanity.com.au) — NCT04289467 — 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:

The child must be between 12 and 36 months old (1 to 3 years old)
The child must have been diagnosed with infantile spasms (a type of seizure disorder in babies and toddlers)
The child must still be having epileptic spasms even after being treated with two standard medications (ACTH and vigabatrin)

Who may not be able to join:

The child has a serious pre-existing heart or cardiovascular condition
The child has used any cannabis-related product in the 14 days before the screening appointment
The child has started or had their dose adjusted for any second-line infantile spasms treatment in the 14 days before the screening appointment
The child has had a vagal nerve stimulator (a small device implanted to help control seizures) fitted within the 14 days before the screening appointment
The child has started and is continuing a ketogenic diet (a special high-fat, low-carbohydrate diet sometimes used for seizures) within the 3 months before the screening appointment

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 19 July 2026

Phase 2: approximately ~30% 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

Principal Investigator: Daniel Shrey, MD, Children's Hospital of Orange County

Phone: 714-509-8972

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: NCT04289467

Sponsor: Children's Hospital of Orange County

Phase: Phase 2

Status: Recruiting

Condition: Epilepsy

Trial contact: 714-509-8972

More information: https://clinicaltrials.gov/study/NCT04289467

Eligibility summary (AI generated)

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

Who might be able to join this trial:

The child must be between 12 and 36 months old (1 to 3 years old)
The child must have been diagnosed with infantile spasms (a type of seizure disorder in babies and toddlers)
The child must still be having epileptic spasms even after being treated with two standard medications (ACTH and vigabatrin)

Who may not be able to join:

The child has a serious pre-existing heart or cardiovascular condition
The child has used any cannabis-related product in the 14 days before the screening appointment
The child has started or had their dose adjusted for any second-line infantile spasms treatment in the 14 days before the screening appointment
The child has had a vagal nerve stimulator (a small device implanted to help control seizures) fitted within the 14 days before the screening appointment
The child has started and is continuing a ketogenic diet (a special high-fat, low-carbohydrate diet sometimes used for seizures) within the 3 months before the screening appointment

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 19 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 2

Sponsor

Children's Hospital of Orange County

Registry

ClinicalTrials.gov

Start date

16 June 2023

Est. completion

31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Electroclinical response (Efficacy)

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: 19 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