Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

Yoshino Neurology Clinic

Status and phase

Unknown

Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: YAM80

Study type

Interventional

Funder types

Other

Identifiers

YAM80-01

Details and patient eligibility

About

The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).

Enrollment

25 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged between 25 and 65 years
ALS patients who can visit the clinic for six months
Forced Vital Capacity (FVC) > 70%
Patients who can walk by themselves
Change in ALSFRS-R score from -1 to -4 during 12 weeks before the initial administration
Patients who are willing to give informed consent

Exclusion criteria

Tracheotomy and invasive ventilation
Pregnant or possibly pregnant female patients
Female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration
Patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases.
Patients who are being treated with investigational drugs
Patients who are treated with other ALS drugs within 2 weeks prior to the first administration