Clinical Research Directory

Key Inclusion Criteria: * Definite ALS or Probable ALS using the El Escorial criteria. * Symptom onset of ≤18 months at screening. * Slow vital capacity (SVC) greater or equal to 60% predicted. * Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening. * Able to swallow a capsule. Key Exclusion Criteria: * Presence of tracheostomy or permanent assisted ventilation. * Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block. * Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study. * Clinically significant and/or unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and/or to study completion. * Use of medications that prolong QT interval. * Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides. * Confirmed mutation in the SOD1, FUS or C9orf72 gene. * Pregnancy.