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ALS drug edaravone shows promise in slowing disease progression

NCT ID NCT00330681

Disease control Sponsor: Shionogi 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This Phase 3 trial tested the drug edaravone (MCI-186) in 206 people with ALS. Participants received daily intravenous infusions for 14 days, followed by a rest period, repeated over 24 weeks. The goal was to see if edaravone could slow the decline in physical function compared to a placebo. The study measured changes in the ALS Functional Rating Scale (ALSFRS-R) and monitored safety.

What this could mean

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

Active substance
Edaravone (also called MCI-186 or Radicut), given as an intravenous infusion
What this could lead to
If successful, this could provide a treatment option that slows the progression of ALS, helping patients maintain function for longer.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all ALS patients. The benefit may be modest, and side effects from the infusion are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

206 people

The number who actually took part.

Started

May 2006

Finished

Sep 2008

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

20 to 75 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.

Inclusion Criteria: * Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House. * Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life. * Patients of less than 3 years after the onset of ALS. * Patients whose progress of the condition during 12 weeks before administration meet other requirements. Exclusion Criteria: * Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, severe heart disease, severe renal disease and so on, or they need to be administered antibiotics to infection. * Patients who complain the difficulty in breathing caused by deteriorating the respiratory function. * Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone. * Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception. * Patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present. * In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

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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 (ALS)

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