Phase 3 Motor Neurone Disease Trial, Recruiting NCT06126315 Sponsor: Mario Negri Institute for Pharmacological Research Condition: Motor Neurone Disease
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Phase 3 Motor Neurone Disease Trial, Recruiting

NCT06126315
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 are 18 years of age or older
  • You have been diagnosed with ALS (Lou Gehrig's disease) using a specific set of diagnostic standards called the "Gold Coast Criteria"
  • Your ALS symptoms (such as limb weakness or swallowing/speech difficulties) started less than 24 months ago at the time of joining the trial
  • You are still able to manage everyday tasks such as swallowing, handling utensils, and walking at an acceptable level (confirm with trial site)
  • Your lungs are working well enough, with breathing capacity at 80% or above of what is considered normal for you
  • Your ALS has been measurably getting worse over time, at a rate that meets a specific threshold based on a standard ALS scoring tool (confirm with trial site)
  • You are able to understand what the trial involves and follow its requirements
  • You are able to sign a consent form yourself, or have a legal representative do so on your behalf
  • You have been taking riluzole (a standard ALS medication) at 50mg twice a day for at least 4 weeks before joining
  • Your thinking and memory are considered intact by the lead doctor running the trial

Who may not be able to join:

  • You have had polio in the past, or currently have an active infection
  • You have a different type of motor neuron disease other than ALS
  • You have another condition affecting your body in a way that could interfere with how the trial measures its results (confirm with trial site)
  • You have a serious health condition, such as a heart problem or cancer, that could affect your survival or physical ability within the next 12 months
  • You have previously used a substance called ALCAR (acetyl-L-carnitine) for any reason
  • You have a history of not following through with previous medical treatments
  • You have taken part in another experimental treatment within the last 3 months before your screening visit (a 3-month waiting period would be required)
  • You are a woman who is breastfeeding, or who could become pregnant and is not using adequate contraception — or a man who is unwilling or unable to use contraception during the treatment and for 3 months afterward
  • You are unable or unwilling to understand and follow the study requirements
  • You are unwilling or unable to take riluzole

⚠️ 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

Principal Investigator: Elisabetta Pupillo, PharmD, Istituto Di Ricerche Farmacologiche Mario Negri

Phone: 00390239014605

Australian sites

Concord Hospital, Sydney,
+61 02 9767 8461

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
Mario Negri Institute for Pharmacological Research
Registry
ClinicalTrials.gov
Start date
26 March 2025
Est. completion
1 April 2027

Where this trial is recruiting

🇦🇺 Australia 🇮🇹 Italy

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

Primary endpoints

self-sufficient

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