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

CompletedPhase 1

Sponsor: Shionogi

Conditions: Japanese Patients With ALS

Interventions: MT-1186

Countries: Japan

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

Eligibility overview

Sex: ALL

Age: 20 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 \<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

Locations (1)

Tokyo, Japan