Table 1 Schedule of study procedures
Screening | Treatment and evaluation | |||||
|---|---|---|---|---|---|---|
Baseline | Final | |||||
Visit | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Follow-up |
Schedule | Week −4 to Day 0 | Week 0 | Week 4 | Week 8 | Week 12 | Week 16 |
Informed consent | ✓ | |||||
Demographic characteristics | ✓ | |||||
Medical history | ✓ | |||||
Inclusion/Exclusion criteria | ✓ | |||||
Chest x-ray | ✓ | |||||
Pregnancy test | ✓ | ✓ | ||||
Electrocardiogram | ✓ | ✓ | ||||
Randomization | ✓ | |||||
Medications | ✓ | ✓ | ✓ | ✓ | ✓ | |
Vital sign | ✓ | ✓ | ✓ | ✓ | ✓ | |
Body weight | ✓ | ✓ | ✓ | ✓ | ✓ | |
Pulmonary function test (FEV1/FVC) | ✓ | ✓ | ✓ | ✓ | ✓ | |
Blood testsa | ✓ | ✓ | ✓ | ✓ | ✓ | |
K-ALSFRS-R | ✓ | ✓ | ✓ | ✓ | ✓ | |
Short Form Health Survey 8 | ✓ | ✓ | ✓ | ✓ | ||
Medical Research Council Scale for muscle strength | ✓ | ✓ | ✓ | ✓ | ||
Visual Analogue Scale for Pain | ✓ | ✓ | ✓ | ✓ | ||
Measurement of Muscular Atrophy | ✓ | ✓ | ✓ | ✓ | ||
Hamilton Rating Scale for Depression | ✓ | ✓ | ✓ | ✓ | ||
Fatigue Severity Scale | ✓ | ✓ | ✓ | ✓ | ||
O2 saturation and CO2 pressure test | ✓ | ✓ | ✓ | ✓ | ||
Provision/collection of test medication and placebo | ✓ | ✓ | ✓ | ✓ | ||
Adverse events assessment | ✓ | ✓ | ✓ | ✓ | ||
Patient Global Impression of Change | ✓ | |||||