ALS drug edaravone shows promise in slowing disease progression
NCT ID NCT00424463
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study tested the drug edaravone (MCI-186) in 181 people with ALS, a progressive nerve disease. Participants received either edaravone or a placebo through IV infusions over 24 weeks. The goal was to see if edaravone could slow the decline in physical function. Results suggested a modest benefit in some patients, but the effect was not large and the drug requires ongoing treatment.
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 known as MCI-186 or Radicut)
- What this could lead to
- If successful, this could confirm edaravone as a treatment that slows the progression of ALS, helping patients maintain function longer.
- What could go wrong
- This is a completed Phase 3 trial, but results may not apply to all ALS patients. The benefit was modest and only seen in a specific subgroup. Edaravone requires regular IV infusions and may cause side effects like bruising or allergic reactions.
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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
-
181 people
The number who actually took part.
- Started
-
Jan 2007
- Finished
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May 2009
- 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 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.
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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 ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681. Exclusion Criteria: * 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. * Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT00330681. * Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception. * Patients who are participating in other clinical trials except the study NCT00330681. * 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
National Hospital Organization Miyagi National Hospital
Watari-gun, Miyagi, Japan
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