Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
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