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Could an old asthma drug slow ALS? new trial aims to find out

NCT ID NCT04057898

Disease control Sponsor: MediciNova 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This clinical trial tests whether ibudilast (MN-166), a drug previously used for asthma, can slow the progression of amyotrophic lateral sclerosis (ALS). The study involves 234 adults with ALS, who will receive either ibudilast or a placebo for 12 months, followed by a 6-month open-label phase where everyone gets the drug. The main goal is to see if ibudilast helps maintain physical function and improves survival.

What this could mean

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

Active substance
Ibudilast (MN-166)
What this could lead to
If it works, this could point toward a treatment that slows the progression of ALS and extends survival.
What could go wrong
This is a mid-to-late-stage trial, but ALS is a very difficult disease to treat. The drug may not show a meaningful benefit over placebo, and side effects are possible.
Why investors are watching

MediciNova is a very small company, so this late-stage trial of its drug MN-166 in ALS patients is a make-or-break event. The trial tests whether the drug slows the disease over 12 months compared to a placebo, and the result will largely determine the company's future.

If it works: If the trial shows MN-166 slows ALS, MediciNova could have a viable treatment for a serious disease with few options. That success could lead to regulatory approval and a commercial product.

If it fails: Most drugs fail in late-stage trials, and a negative result here would likely leave MediciNova without a major pipeline asset. A delay in the readout could also hurt the company, given its small size and dependence on this single trial.

AI-written from the trial record. Speculative, and not investment advice.

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

234 people

The number who actually took part.

Started

May 2020

Expected to finish

Apr 2028

An estimate. End dates often move.

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 80 years

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.

Major Inclusion Criteria: * Male or female subjects age 18 - 80 years, inclusive; * Diagnosis of familial or sporadic ALS as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS \[clinically definite, clinically probable, probable-laboratory-supported\]; * ALS onset of ≤18 months from first clinical signs of weakness prior to screening; * If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiation of study drug; * If currently using edaravone, subject should have completed at least 14 days of their initial treatment cycle prior to initiation of study drug; * Last documented pulmonary function test result (i.e., slow vital capacity or forced vital capacity) must be greater than or equal to 70% predicted; * Able to swallow study medication capsules; * No known allergies to the study drug or its excipients; * Received pneumococcal vaccine within 6 years prior to starting clinical trial. Major Exclusion Criteria: * Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT \>3 times upper limit of normal); * Currently diagnosed with a clinically significant psychiatric disorder or dementia that would preclude evaluation of symptoms; * Currently use or treated with parenteral (intramuscular or intravenous) high dose (\>25 mg/week) Vitamin B12 within 30 days prior to study drug administration; * Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator; * Currently participating, or has participated in a study with an investigational or marketed compound or device within 30 days or 5 half-lives, whichever is shorter, prior to signing the informed consent; * Use of tracheostomy or \>22/24-hour ventilatory support.

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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

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Hennepin Healthcare Research Institute

    Minneapolis, Minnesota, 55415, United States

  • Hopital de L'Enfant-Jesus, CHU de Quebec-Universite Laval

    Québec, G1J 1Z4, Canada

  • Indiana University IU Health Neuroscience Center

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • McMaster University Medical Center

    Hamilton, Ontario, L8N 3Z5, Canada

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5, Canada

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2G3, Canada

  • University of California

    Orange, California, 92868, United States

  • University of Saskatchewan - Sastakoon Hospital

    Saskatoon, Saskatchwean, S7K 0M7, Canada

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

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