Phase 3 Motor Neurone Disease Trial, Recruiting NCT07322003 Sponsor: Prilenia Condition: Motor Neurone Disease
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Phase 3 Motor Neurone Disease Trial, Recruiting

NCT07322003
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:

  • You have been diagnosed with definite or probable ALS (also known as Lou Gehrig's disease), confirmed using a standard set of diagnostic guidelines called the El Escorial criteria.
  • Your ALS symptoms started no more than 18 months before your screening appointment.
  • Your lungs are working at 60% or more of the expected level for someone of your age and size, measured by a breathing test called slow vital capacity.
  • Your score on a specific ALS risk and survival prediction calculator (called the TRICALS Risk Profile, based on the ENCALS model) falls between -6 and -2 at your screening appointment (confirm with trial site if unsure what this means for you).
  • You are able to swallow a capsule.

Who may not be able to join:

  • You have a tracheostomy (a breathing tube in your throat) or are on permanent breathing support.
  • You have a serious heart condition, a history of significant irregular heartbeat, uncontrolled atrial fibrillation, a certain type of rapid heartbeat (ventricular tachycardia), or a specific heart electrical abnormality called left bundle branch block.
  • You have an unstable mental health condition, significant memory or thinking problems, dementia, or a substance use problem that could affect your ability to consent to or take part in the study.
  • You have another significant or unstable health condition (other than ALS) that could put you at risk or affect your ability to complete the study.
  • You are currently taking any medications known to affect the heart's electrical rhythm in a specific way (called QT interval prolongation) (confirm with trial site).
  • You have previously been treated with pridopidine, gene therapy, or a type of drug called antisense oligonucleotides.
  • You have a confirmed genetic mutation in the SOD1, FUS, or C9orf72 gene.
  • You are pregnant.

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 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

Phone: 857-574-5755

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
Prilenia
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
1 March 2028

Where this trial is recruiting

🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇱 Poland 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality

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