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

Study Purpose:

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

Study Status:

Not recruiting


Japanese Patients With ALS

Study Type:


Type of Intervention:


Intervention Name:





Phase 1

Study Chair(s)/Principal Investigator(s):

General Manager, Mitsubishi Tanabe Pharma Corporation ID:


Neals Affiliated?


Coordinating Center Contact Information

Study Sponsor:

Mitsubishi Tanabe Pharma Corporation

Estimated Enrollment:


Estimated Study Start Date:

01 / 24 / 2020

Estimated Study Completion Date:

04 / 22 / 2020

Posting Last Modified Date:

10 / 01 / 2020

Date Study Added to

02 / 05 / 2020

Minimum Age:

20 Years

Maximum Age:

80 Years

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

Investigational site