Phase 2 Epilepsy Trial, Recruiting NCT05419492 Sponsor: Encoded Therapeutics Condition: Epilepsy
Back to Epilepsy

Phase 2 Epilepsy Trial, Recruiting

NCT05419492
Recruiting Phase 2 🇦🇺 Australian site

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:

  • Children aged 6 months to under 36 months (for Part 1A), 48 months to under 18 years (for Part 1B), or 6 months to under 48 months (for Part 2), depending on which part of the trial is relevant
  • People who have a specific type of change (called a predicted loss of function variant) in a gene known as SCN1A, which has been identified as harmful or likely harmful
  • People who had their first seizure between the ages of 3 and 15 months
  • People who have been diagnosed with Dravet syndrome, or whose treating doctor has a strong clinical suspicion that they have Dravet syndrome
  • People who are already taking at least one regular medication to help prevent seizures

Who may not be able to join:

  • People who have another genetic change or additional health condition that could affect how Dravet syndrome typically presents
  • People who have a known structural or blood vessel abnormality in the brain, as shown by an MRI or CT scan
  • People who have a physical abnormality that might interfere with the flow of cerebrospinal fluid (the fluid around the brain and spinal cord), or who already have a shunt (a device that drains fluid from the brain) in place
  • People who have taken a specific type of medication called sodium channel blockers during the pre-dosing seizure monitoring period (confirm with trial site)
  • People who have had no seizures for four weeks in a row within the 90 days before signing the consent form
  • People who have previously received any type of gene therapy or cell therapy
  • People who are currently taking part in another clinical trial or receiving an experimental treatment
  • People who have a significant liver condition

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 14 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: Salvador Rico, M.D., Ph.D, Encoded Therapeutics

Phone: +1 (650) 398-4301

Australian sites

The Royal Children's Hospital, Melbourne,

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.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Encoded Therapeutics
Registry
ClinicalTrials.gov
Start date
14 May 2024
Est. completion
1 January 2028

Where this trial is recruiting

🇦🇺 Australia 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percent change in monthly countable seizure frequency (MCSF) between the Pre-Dosing Seizure Period and the Post-Dosing Assessment Period.

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: 14 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