Phase 3 Epilepsy Trial, Recruiting NCT05066217 Sponsor: Epygenix Condition: Epilepsy
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Phase 3 Epilepsy Trial, Recruiting

NCT05066217
Recruiting Phase 3

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:

  • People aged 2 to 55 years old at the time of screening
  • People (or their parent or legal guardian) who are willing and able to give written consent to participate
  • People who have been diagnosed with Lennox-Gastaut Syndrome (LGS), which includes all of the following: evidence of at least one type of major, countable motor seizure; a brain wave test (EEG) showing results consistent with LGS; abnormal cognitive (thinking and learning) development; and seizures that began at age 11 or younger

Who may not be able to join:

  • People who are known to be sensitive or allergic to, or have previously been given, the drug clemizole HCl
  • People with a known history of long QT syndrome (a heart rhythm condition) or any significant heart tracing (ECG) abnormality, such as a recent heart attack or a serious irregular heartbeat
  • People who have a family history of sudden cardiac death, unexplained death, or death caused by a heart rhythm problem that may be linked to a condition called QT prolongation
  • People whose seizures are caused by illicit drug or alcohol use, infection, a brain tumour, nerve damage, a degenerative brain condition, a metabolic illness, a lack of oxygen to the brain within the past 6 months that required resuscitation, or any other condition that, in the trial doctor's opinion, could affect seizure control
  • People who have had epilepsy surgery within the 6 months before screening, or who have epilepsy surgery planned during the study
  • People who are currently taking the drug fenfluramine at the same time
  • People who have previously taken or are currently taking the drug lorcaserin

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 26 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

Principal Investigator: Amit Ray, MD, Harmony Biosciences Management, Inc.

Phone: (302) 559-4320

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 3
Sponsor
Epygenix
Registry
ClinicalTrials.gov
Start date
9 April 2025
Est. completion
1 November 2026

Where this trial is recruiting

🇮🇹 Italy 🇵🇱 Poland 🇺🇸 United States

Primary endpoints

Percent Change in CMMS-28

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: 26 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