Tiny study tests ALS drug in patients with feeding tubes
NCT ID NCT04254913
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This early-stage study looked at how the body handles a single dose of oral edaravone in 6 Japanese ALS patients who have a feeding tube (gastrostomy). The goal was to measure drug levels in the blood and urine, not to test if it works. No treatment benefit was evaluated.
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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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6 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Apr 2020
- 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 80 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 80 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 * ALS Patients with gastrostomy * 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 \<15.0 or \>30.0, or a body weight of \<40 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
Chiba, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.