Phase 3 Epilepsy Trial, Recruiting NCT05716100 Sponsor: Xenon Pharmaceuticals Inc. Condition: Epilepsy
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Phase 3 Epilepsy Trial, Recruiting

NCT05716100
Recruiting Phase 3 🇦🇺 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:

  • You are willing to sign a written consent form after being fully informed about the study and its risks
  • You have been diagnosed with focal epilepsy (a type of epilepsy that starts in one specific area of the brain) for at least 2 years, and have already tried at least 2 seizure medications at proper doses without achieving lasting seizure freedom
  • You have been taking a steady dose of 1 to 3 approved seizure medications for at least one month before the study begins, and are able to continue this throughout the trial
  • You are able to keep an accurate written diary of your seizures

Who may not be able to join:

  • Your brain wave test (EEG) has shown a pattern that does not match focal epilepsy
  • You have only ever had a specific mild type of focal seizure with no movement, seizures caused by psychological factors, seizures that start across the whole brain, or certain severe epilepsy conditions such as Lennox-Gastaut syndrome
  • Your seizures are caused by drug or alcohol use, an active infection, a tumor, or certain other ongoing diseases affecting the brain or nervous system
  • You have had a dangerous prolonged seizure, or seizures so frequent they could not be counted individually, in the 12 months before the study starts
  • You have had brain surgery for epilepsy within the past year, or radiation-based brain treatment within the past 2 years
  • You have any other health condition or personal situation that the study doctor believes could put you at risk or prevent you from following the study plan

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 23 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: Xenon Medical Director, Xenon Pharmaceuticals Inc.

Phone: 1-604-484-3300

Australian sites

Royal Prince Alfred Hospital, Camperdown, New South Wales
Prince of Wales Hospital, Randwick, New South Wales
Westmead Hospital, Westmead, New South Wales
Alfred Hospital, Melbourne, Victoria
Austin Health, Melbourne, Victoria
Royal Melbourne 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 3
Sponsor
Xenon Pharmaceuticals Inc.
Registry
ClinicalTrials.gov
Start date
9 May 2023
Est. completion
1 October 2026

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇱 Chile 🇭🇷 Croatia 🇨🇿 Czechia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇪🇸 Spain 🇺🇸 United States

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

Primary endpoints

Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.

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: 23 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