Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS (PREVAiLS)

Other illness

• 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

Other

• Presence of tracheostomy or permanent assisted ventilation

• Age 18 to 80 years (both inclusive), at the time of signing the informed consent
• Definite ALS or Probable ALS using the El Escorial criteria
• Symptom onset of ≤18 months at screening
• 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