Phase 2 Motor Neurone Disease Trial, Recruiting NCT07660614 Sponsor: Leal Therapeutics, Inc Condition: Motor Neurone Disease
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Phase 2 Motor Neurone Disease Trial, Recruiting

NCT07660614
Recruiting Phase 2

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 ALS (also known as Lou Gehrig's disease) using a specific set of medical guidelines called the Gold Coast criteria.
  • Your ALS symptoms started less than 36 months (3 years) before the study screening visit.
  • Your lungs are working at 50% or more of the expected level for a person of your age and size, based on a breathing test.
  • Your body weight falls within a healthy range — specifically, your Body Mass Index (BMI) is between 18 and 40 (confirm with trial site if unsure of your BMI).

Who may not be able to join:

  • You have a significant medical condition that, in the doctor's opinion, could affect your safety, interfere with the study results, or make it unlikely you would be able to complete the trial.
  • You have a history of abnormalities in the brain or spine, seen on an MRI or CT scan, that could make certain procedures (such as a lumbar puncture, or "spinal tap") unsafe or complicated.
  • You have previously received certain types of advanced treatments, including antisense oligonucleotide therapy, gene-silencing therapy (siRNA), stem cell therapy, or gene therapy, for any condition.
  • You have had a tracheostomy (a surgical opening in the throat to help with breathing).
  • You currently have or have had HIV, Hepatitis B, or Hepatitis C infection.
  • You have an implanted device that drains fluid from the brain or spine, or an implanted vascular (blood vessel) device.
  • You have a condition that puts you at risk of uncontrolled bleeding.
  • You are currently pregnant or breastfeeding.

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 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 Monitor, Leal Therapeutics, Inc

Phone: 267-503-4800

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
Leal Therapeutics, Inc
Registry
ClinicalTrials.gov
Start date
29 April 2026
Est. completion
1 June 2031

Where this trial is recruiting

🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇸🇪 Sweden

Primary endpoints

Safety and Tolerability (Adverse Events); Safety and Tolerability (Clinical Laboratory Tests); Safety and Tolerability (Vital Signs); Safety and Tolerability (Physical and Neurological exams); Safety and Tolerability (ECGs - heart rate); Safety and Tolerability (ECGs - QRS); Safety and Tolerability (ECGs - QT); Safety and Tolerability (ECGs - QTc); Safety and Tolerability (ECGs - PR intervals)

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