Overview
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy
Eligibility
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