Phase 2 Epilepsy Trial, Recruiting NCT06798896 Sponsor: Supernus Pharmaceuticals, Inc. Condition: Epilepsy
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Phase 2 Epilepsy Trial, Recruiting

NCT06798896
Recruiting Phase 2

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 have been diagnosed with focal epilepsy that has not responded well to treatment, as confirmed by a specialist epilepsy review board.
  • You have tried at least 2 different seizure medications at appropriate doses but have not been able to stay seizure-free on them.
  • You are able to keep a daily electronic seizure diary (a caregiver can help with this if needed).
  • Your body mass index (BMI) is between 18.0 and 40.0 — this is a measure of height and weight (confirm with trial site if unsure).
  • You have been on a steady dose of 1 to 4 seizure medications for at least 28 days before your first study visit, and if you follow a special diet for epilepsy, you have been on it for at least 1 month before joining.
  • You have had at least 4 clearly observable focal seizures during the baseline diary recording period, with no gap of more than 21 consecutive seizure-free days, and you have filled in your diary on at least 80% of those days.

Who may not be able to join:

  • You have taken a supplement called huperzine A in the past 6 months.
  • You have been diagnosed with a combined type of epilepsy involving both focal and widespread seizures, significant developmental delays, and multiple seizure types (such as Lennox-Gastaut syndrome), confirmed by a brain wave test (EEG).
  • You have a history of, or currently experience, non-epileptic episodes that could be mistaken for seizures by you or the study team.
  • Your seizures are not clearly observable and would be difficult to count and record.
  • You have a history of seizures that occur in rapid clusters and cannot be counted individually.
  • You have had a prolonged, dangerous seizure episode (called status epilepticus) within the 6 months before joining.
  • You have had a brain stimulation device (such as vagus nerve stimulation or deep brain stimulation) implanted or switched on within the past year, or epilepsy surgery within the past year; or your device settings have not been stable for at least 3 months (battery changes are allowed, but settings must stay the same throughout the study).
  • You have had thoughts of suicide with some intention to act, or a specific plan to act, in the past year; or you have attempted suicide in the past 2 years; or you have made more than one suicide attempt in your lifetime.
  • You are regularly taking non-seizure medications that strongly affect a brain chemical system called the cholinergic system (confirm with trial site if unsure whether your medications apply).
  • You have had more than 2 allergic reactions to seizure medications, or one serious allergic reaction to a seizure medication.
  • The study doctor believes, for any other reason, that joining the study would not be right for you.

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 27 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: Maciej Gasior, MD, PhD, Supernus Pharmaceuticals, Inc.

Phone: 240-403-5838

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
Supernus Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
30 December 2024
Est. completion
1 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance 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: 27 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