Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS (PREVAiLS)
Key facts
- Where
- Berlin, Bonn, Hanover, Jena, Luebeck és Ulm, NémetországSee the 6 sites
- Phase
- 3. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországTaking people
- Universitaetsklinikum Bonn AöRBonn, NémetországTaking people
- DIAKOVERE Krankenhaus gGmbHHanover, NémetországTaking people
- Universitaetsklinikum Jena KöRJena, NémetországTaking people
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, NémetországTaking people
- Universitaetsklinikum Ulm AoRUlm, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ferrer Internacional S.A.
- Trial code
- EU 2025-524002-16-00
- Record updated
- 2026. május 14.
- Original description
To evaluate the effect of pridopidine on disease progression in participants with ALSRead full original descriptionShow less
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants with Amyotrophic Lateral Sclerosis
To evaluate the effect of pridopidine on disease progression in participants with ALS
Inclusion: 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.
Exclusion: 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; Presence of tracheostomy or permanent assisted ventilation.