Amyotrophic Lateral Sclerosis
Conditions
Sponsors
Tanabe Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety Adverse events | — |
Countries
Japan
Contacts
Public ContactClinical Trials Information Desk
Tanabe Pharma Corporation
Outcome results
None listed