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

Mitsubishi Tanabe Pharma

Status and phase

Completed

Phase 1

Conditions

Japanese Patients With ALS

Treatments

Drug: MT-1186

Study type

Interventional

Funder types

Industry

Identifiers

MT-1186-J04

Details and patient eligibility

About

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

Enrollment

9 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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 <18.0 or >30.0, or a body weight of <50 kg
Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason