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Massive ALS trial tests multiple drugs at once to find a way to slow the deadly disease

NCT ID NCT04297683

Disease control Sponsor: Merit E. Cudkowicz, MD 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 22, 2026 · Updated 2 times

Summary

This study is testing several experimental treatments at the same time to see if they can slow down ALS, a disease that weakens muscles and gets worse over time. About 1,500 adults with early-stage ALS will take part. The goal is to find treatments that help people stay stronger and live longer.

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.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2020

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria. 2. Age 18 years or older. 3. Capable of providing informed consent and complying with study procedures, in the SI's opinion. 4. Time since onset of weakness due to ALS ≤ 24 months at the time of the Master Protocol Screening Visit. 5. Vital Capacity ≥ 50% of predicted capacity at the time of the Master Protocol Screening Visit measured by Slow Vital Capacity (SVC), or, if required due to pandemic-related restrictions, Forced Vital Capacity (FVC) measured in person. 6. Participants must either not take riluzole or be on a stable dose of riluzole for ≥ 30 days prior to the Master Protocol Screening Visit. 7. Participants must either not take edaravone or have completed at least one cycle (typically 14 days) of edaravone prior to the Master Protocol Screening Visit. 8. Participants must have the ability to swallow pills and liquids at the time of the Master Protocol Screening Visit and, in the SI's opinion, have the ability to swallow for the duration of the study. 9. Geographically accessible to the site. Exclusion Criteria: 1. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to SI's judgment (e.g., cardiovascular instability, systemic infection), or clinically significant laboratory abnormality or EKG changes. Clinically significant abnormal liver or kidney function is exclusionary. The following values \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73m2\] are exclusionary regardless of clinical symptoms. 2. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion. 3. Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years. 4. Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the Master Protocol Screening Visit. 5. Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational). 6. If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception, for the duration of the trial and for 3 months, or as specified in each RSA, after discontinuing study treatment. 7. If male of reproductive capacity, unwilling to use effective contraception for the duration of the trial and for 3 months, or as specified in each RSA, after discontinuing study treatment. 8. Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the SI's opinion. 9. If a participant is being re-screened, the disqualifying condition has not been resolved, or the mandatory wash-out duration has not occurred.

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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.

Amyotrophic lateral sclerosis

Contacts and locations

Locations

  • Atrium Health

    Charlotte, North Carolina, 28207, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Austin Neuromuscular Clinic

    Austin, Texas, 78759, United States

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University

    New York, New York, 10032, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Dent Neurologic Institute

    Amherst, New York, 14226, United States

  • Duke University

    Durham, North Carolina, 27702, United States

  • Essentia Health

    Duluth, Minnesota, 55805, United States

  • Forbes Norris MDA/ALS Research Center, California Pacific Medical Center

    San Francisco, California, 94115, United States

  • George Washington University

    Washington D.C., District of Columbia, 20037, United States

  • Georgetown University

    Washington D.C., District of Columbia, 20007, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital for Special Care

    New Britain, Connecticut, 06053, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • Jefferson Weinberg ALS Center, Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103, United States

  • Lewis Katz School of Medicine at Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • Loma Linda University Health

    Loma Linda, California, 92354, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55902, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Mount Sinai

    New York, New York, 10003, United States

  • Neurology Associates, P.C./Somnos Clinical Research

    Lincoln, Nebraska, 68506, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Nova Southeastern University

    Davie, Florida, 33024, United States

  • Ochsner Health System

    New Orleans, Louisiana, 70115, United States

  • OhioHealth Research Institute

    Westerville, Ohio, 43082, United States

  • Penn State Hershey

    Hershey, Pennsylvania, 17033, United States

  • Providence Brain and Spine Institute ALS Center

    Portland, Oregon, 97213, United States

  • SUNY Upstate

    Syracuse, New York, 13202, United States

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83704, United States

  • Saint Louis University

    St Louis, Missouri, 63104, United States

  • Spectrum Health/Corewell Health

    Grand Rapids, Michigan, 49525, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Texas Neurology

    Dallas, Texas, 75214, United States

  • The Ohio State University

    Columbus, Ohio, 43221, United States

  • UC San Diego

    La Jolla, California, 92037, United States

  • UTHSCSA

    San Antonio, Texas, 78229, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California, Irvine

    Orange, California, 92868, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Fairway, Kansas, 66205, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Massachusetts Medical School

    North Worcester, Massachusetts, 01655, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota Medical School

    Minneapolis, Minnesota, 55455, United States

  • University of Missouri Health Care

    Columbia, Missouri, 65212, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107, United States

  • University of Pittsburg Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Commonwealth University

    Henrico, Virginia, 23233, United States

  • Wake Forest Health Science

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale University

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.