Table 2.

Inclusion criteria.

1. Probable laboratory-supported, probable, or definite ALS, as defined by El Escorial Revised ALS diagnostic criteria at screening visit (month−3) (23)

2. Disease duration ≤ 18 months at screening visit (month−3)

3. Able to perform reproducible pulmonary function tests at screening visit (month−3)

4. Forced vital capacity or slow vital capacity ≥70% of normal at screening visit (month−3)

5. Stable on riluzole treatment for 3 months in the lead-in period

6. Signed informed consent at screening visit (month−3)