Phase 2 Motor Neurone Disease Trial, Recruiting NCT07071935 Sponsor: University of Pennsylvania Condition: Motor Neurone Disease
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Phase 2 Motor Neurone Disease Trial, Recruiting

NCT07071935
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 diagnostic guidelines called the "Gold Coast Criteria," and this diagnosis was made within the last 6 months
  • You are 18 years of age or older
  • You are willing and able to take part in all parts of the study
  • You are able to sign and date a consent form agreeing to participate

Who may not be able to join:

  • You currently use, have previously used, or have been told to use a breathing support machine such as BiPAP, a respiratory assist device, a home ventilator, or CPAP
  • Your lung capacity (the amount of air your lungs can hold) is below 50% of what is considered normal for someone your age and size
  • Your breathing muscle strength, measured by a specific breathing test, falls above a certain threshold, meaning your breathing muscles are weaker than a set limit (confirm with trial site)
  • You regularly use supplemental oxygen at any point during the day
  • You are currently enrolled in hospice care
  • You currently have a tracheostomy (a breathing tube surgically placed in your throat)
  • You have a history of sleep apnea for which a breathing support device was used or recommended
  • You have had surgery on your chest, abdomen, face, or eyes in the past 6 weeks
  • You are currently coughing up blood
  • You have had a heart attack in the past 4 weeks
  • You have certain serious health conditions that make the use of breathing support machines unsafe, such as severe drowsiness or confusion, broken bones in the face, a collapsed lung, or a blockage in your airway (confirm with trial site)
  • You have cognitive difficulties (such as problems with memory or thinking) that would prevent you from completing the study, as decided by your neurologist

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 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: Jason T Ackrivo, MD, MSCE, Perelman School of Medicine at the University of Pennsylvania

Phone: 215-829-3053

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
Registry
ClinicalTrials.gov
Start date
11 June 2026
Est. completion
1 May 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Time to first use of non-invasive ventilation

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