Small study tests how oral ALS drug works in the body
NCT ID NCT04176224
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This early-stage study looked at how a single dose of oral edaravone moves through the bodies of 9 Japanese adults with ALS. The main goal was to measure drug levels in the blood and urine, not to test if it helps symptoms. Researchers also tracked any side effects. The study is complete and helps guide future research.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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9 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Sep 2019
- Lead sponsor
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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
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20 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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: The key criteria are listed below. * Patients aged between 20 and 75 years at the time of informed consent * Japanese patients * Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie House criteria * Patients who can consent to contraception * Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study Exclusion Criteria: The key criteria are listed below. * Patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy * Patients undergoing treatment for malignancy * Patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except ALS) and infections requiring antibiotics. Patients who have a problem in general condition and are judged ineligible by the Investigator * Body mass index (BMI) of \<18.0 or \>30.0, or a body weight of \<50 kg * Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
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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
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Investigational site
Tokyo, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.