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Completed
NCT04176224
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
Conditions: Japanese Patients With ALS
Sex: All
Ages: 20 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 9
Sponsor: Shionogi
Location: Investigational site Tokyo
Summary
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis
Eligibility Criteria
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 \30.0, or a body weight of \
Source: ClinicalTrials.gov (NCT04176224). StuddyBuddy aggregates publicly available trial information.