Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy

Shionogi6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Japanese Patients With ALS

Interventions

MT-1186DRUG

Suspension

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Investigational site

Chiba, Japan

Outcomes

Primary Outcomes

Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone