Trial participants
FALS, ALS
DISEASES
The trial enrolled patients diagnosed with definite, clinically probable or probable with laboratory support ALS according to revised El Escorial criteria who presented ALS symptoms onset not earlier than 18 months before screening. Inclusion criteria encompassed age between 18 and 75 years old, a forced vital capacity (FVC) exceeding 70% of the predicted value for sex, age, height, and weight, a Body Mass Index above 18 and a body weight over 50 kg, use of riluzole at a stable dose for at least 30 days before screening. Exclusion criteria covered a wide range of diseases and conditions that would make rapamycin use or immunosuppression contraindicated. Patients with known SOD1 mutation or with FALS and family members carrying SOD1 mutation were to be excluded as well, based on contrasting evidence of Rapamycin action in SOD1 models of ALS,