Phase 4 Epilepsy Trial, Recruiting NCT06598449 Sponsor: University of Colorado, Denver Condition: Epilepsy
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Phase 4 Epilepsy Trial, Recruiting

NCT06598449
Recruiting Phase 4

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 are between 12 and 23 months old.
  • You have a change (mutation) in the SCN1A gene that is known or suspected to cause problems, or you have been diagnosed with Dravet syndrome, and you have had at least one prolonged seizure.
  • You have tried at least one seizure medication that does not belong to a group called sodium channel blockers (for example, not lamotrigine, oxcarbazepine, carbamazepine, or eslicarbazepine), and it did not work well enough.
  • Your doctor must send in a detailed statement about your health history, including your diagnosis, gene result, other health conditions, seizure history, and past and current treatments.
  • A heart scan (echocardiogram) must also be sent to the lead study site before you can be fully approved.

Who may not be able to join:

  • Children who have a leaky mitral heart valve (mild or worse) or any leaking of the aortic heart valve may not be eligible.
  • Children who are not gaining weight as expected — specifically, those whose weight is below the 2nd percentile, or whose weight gain has significantly fallen behind their height over time — may not be eligible, because the study drug can reduce appetite and cause weight loss.

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 22 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Kelly Knupp, MD, University of Colorado, Denver

Phone: 720-777-0717

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 4
Registry
ClinicalTrials.gov
Start date
22 October 2024
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percentage of participants that have at least one adverse event

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: 22 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