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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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04176224). StuddyBuddy aggregates publicly available trial information.