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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yoshino Neurology Clinic

Criteria

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