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New drug made available to ALS patients unable to join trials

NCT ID NCT07088159

Disease control Sponsor: Spinogenix Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This expanded access program offers the drug tazbentetol to adults with ALS who cannot join other clinical studies. Participants take one 300 mg pill by mouth each day. The program aims to check the drug's safety and whether it helps control the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tazbentetol (SPG302), a drug taken by mouth once daily
What this could lead to
If it works, this could provide a treatment option for ALS patients who cannot join other clinical trials.
What could go wrong
This is an expanded access program, not a formal trial, so results are limited. The drug's effectiveness and safety are still being studied, and it may not help everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * ALS diagnosis * Age 18 -85 years at time of signing informed consent form * Ineligible for other interventional ALS clinical research participation * Vital Capacity greater than 35% of predicted capacity for age, height, and sex * If currently taking standard of care treatment for ALS, must be on stable dose for at least 30 days prior to taking tazbentetol. * Life expectancy of at least 6 months, according to Investigator's judgement Exclusion Criteria: * Clinically significant and/or unstable medical condition (other than ALS) that would pose a risk to the patient * Known ongoing or clinically uncontrolled cardiac disease * Clinically significant liver disease * Clinical significant cognitive impairment or neurological disorder, as determined by Investigator judgement * Concomitant use of another investigational medical product for treatment of ALS * Unable to reliably and regularly swallow whole oral medications on a daily basis

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALS (amyotrophic lateral sclerosis)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Atlantic Health

    AVAILABLE

    Summit, New Jersey, 07901, United States

    Contact Email: •••••@•••••

  • Baylor College of Medicine

    AVAILABLE

    Houston, Texas, 77030, United States

  • California Pacific Medical Center

    AVAILABLE

    San Francisco, California, 94109, United States

  • Cedar-Sinai Medical Center

    AVAILABLE

    Los Angeles, California, 90048, United States

    Contact Email: •••••@•••••

  • Columbia University Medical Center

    AVAILABLE

    New York, New York, 10032, United States

    Contact Email: •••••@•••••

  • Dartmouth-Hitchcock Medical Center

    AVAILABLE

    Lebanon, New Hampshire, 03756, United States

  • Kaiser Permanente Los Angeles

    AVAILABLE

    Los Angeles, California, 90027, United States

  • Mayo Scottsdale

    AVAILABLE

    Scottsdale, Arizona, 85259, United States

  • NYU Langone Health

    AVAILABLE

    New York, New York, 10017, United States

  • New Mexico VA Health Care System

    AVAILABLE

    Albuquerque, New Mexico, 87108, United States

  • Nova Southeastern University

    AVAILABLE

    Davie, Florida, 33314, United States

  • Synapticure

    AVAILABLE

    Chicago, Illinois, 60640, United States

    Contact Email: •••••@•••••

  • Thomas Jefferson University

    AVAILABLE

    Philadelphia, Pennsylvania, 19107, United States

  • University of Alabama Birmingham

    AVAILABLE

    Birmingham, Alabama, 35233, United States

  • VCU ALS Research Group

    AVAILABLE

    Henrico, Virginia, 23233, United States

    Contact Email: •••••@•••••

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