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

• Status: Completed
• Trial end date: 2020-04-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Edaravone

Criteria

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