Phase 2 Epilepsy Trial, Recruiting NCT06908356 Sponsor: Praxis Precision Medicines Condition: Epilepsy
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Phase 2 Epilepsy Trial, Recruiting

NCT06908356
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:

  • You have been diagnosed with focal onset seizures (seizures that start in one part of the brain) or a type of generalized seizure called idiopathic generalized tonic-clonic seizures (full-body convulsive seizures with no known structural cause).
  • You have had a brain scan (CT or MRI) in the past that ruled out a worsening or progressive cause for your epilepsy.
  • You are currently taking between 1 and 3 approved anti-seizure medications at doses that have been stable for some time.
  • You (or your caregiver) report having at least 2 countable focal onset seizures per month, or at least 1 countable generalized tonic-clonic seizure per month, in the 3 months before the screening period.

Who may not be able to join:

  • You have had seizures in the past 12 months that are psychological or non-epileptic in origin, seizures that only occur in uncountable clusters, or a severe convulsive episode requiring hospitalization and a breathing tube in the past 12 months.
  • You are planning to have brain surgery for epilepsy during the trial.
  • You have had brain surgery for seizures within the past year, or radiation-based brain treatment within the past 2 years.
  • You have schizophrenia, obsessive-compulsive disorder, or another serious mental health condition.
  • You have had an active plan or intent to end your life in the past 6 months, a suicide attempt in the past 2 years, or more than one suicide attempt at any point in your life.
  • You have been diagnosed with cancer or certain blood/lymph system disorders within the past 5 years.
  • You have a history of heart disease, heart rhythm problems, or structural abnormalities of the heart.
  • You are currently pregnant, breastfeeding, have a positive pregnancy test at screening, or plan to become pregnant during the trial or within 14 days of taking the last dose of the study drug.
  • You have taken part in another clinical drug or device trial within the past 30 days (or longer, depending on the drug), or have ever received gene therapy.
  • You have taken a seizure medication called vigabatrin in the last 5 years, unless your vision has been checked and found to be stable on two occasions in the year after stopping it.
  • You have taken or are taking a seizure medication called felbamate, unless you meet specific requirements about how long you have been on it and how recently the dose was changed (confirm with trial site).

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 28 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: Medical Director, Praxis Precision Medicines

Phone: 617-300-8460

Australian sites

Praxis Research Site, Heidelberg,
Praxis Research Site, 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
Praxis Precision Medicines
Registry
ClinicalTrials.gov
Start date
10 January 2025
Est. completion
1 July 2025

Where this trial is recruiting

🇦🇺 Australia 🇪🇸 Spain 🇺🇸 United States

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

Primary endpoints

To evaluate the efficacy of PRAX-628 on seizure frequency in adults with FOS or PGTCS currently taking ASMs

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: 28 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