Clinical Pharmacology Study of Oral Edaravone in ALS Patients with PEG

JRCT ID: jRCT2080225036

Registered date:23/01/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Amyotrophic Lateral Sclerosis
• Date of first enrollment: 24/01/2020
• Target sample size: 9
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc :
INN of investigational material : Edaravone
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for Investigational material :

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcome

Pharmacokinetic
1. Drug concentration in plasma and urine
2. PK parameters
AUC, Cmax, tmax, t1/2, Kel, MRT, CL/F, Vz/F, Vss/F, Ae, Ae%, CLr

Secondary Outcome

Safety
Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

The key criteria are listed below.
1. Patients aged between 20 and 80 years at the time of informed consent
2. Japanese patients
3. 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
4. ALS Patients with gastrostomy
5. Patients who can consent to contraception
6. Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclude criteria

The key criteria are listed below.
1. 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
2. Patients undergoing treatment for malignancy.
3. 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
4. Body mass index (BMI) of <15.0 or >30.0, or a body weight of <40 kg
5. Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason

Related Information

• Primary Sponsor: Mitsubishi Tanabe Pharma Corporation
• Secondary ID(s): NCT04254913,JapicCTI-205129