Phase 3 Epilepsy Trial, Recruiting NCT07010471 Sponsor: Praxis Precision Medicines Condition: Epilepsy
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Phase 3 Epilepsy Trial, Recruiting

NCT07010471
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 have been officially diagnosed with a developmental and epileptic encephalopathy (a brain condition that causes both developmental challenges and seizures).
  • Your seizures first started before the age of 12.
  • You weigh more than 7 kg (about 15.4 lbs) at the time of signing the consent form.

Who may not be able to join:

  • You have a history of certain heart conditions, including left bundle branch block, irregular heart rhythms, Brugada syndrome, a heart condition present from birth, familial short QT syndrome, or a family history of sudden death or serious irregular heart rhythms.
  • You have had 2 or more episodes of severe, prolonged seizures (called convulsive status epilepticus) that required a hospital stay and breathing support (a breathing tube) in the 6 months before the screening visit.
  • Your heart electrical activity reading (called an ECG) shows an abnormal result at screening or at your first study visit (confirm with trial site).
  • If you use a nerve stimulation device, it must have been put in place at least 3 months before screening, and the settings must have been stable for at least 1 month before screening.
  • You have taken part in another experimental drug or device study, or received gene therapy, within the past 30 days or within 5 half-lives of that drug (whichever is longer) before screening.
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the trial or shortly after finishing the study drug.

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 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: Medical Director, Praxis Precision Medicines

Phone: 617-300-8460

Australian sites

Praxis Research Site, Heidelberg, Victoria

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
Praxis Precision Medicines
Registry
ClinicalTrials.gov
Start date
9 July 2025
Est. completion
1 December 2026

Where this trial is recruiting

🇦🇺 Australia 🇧🇷 Brazil 🇺🇸 United States

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

Primary endpoints

To assess the effect of relutrigine on seizure frequency in participants with DEEs compared to 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: 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