Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
Key facts
- Where
- Caserta, Milan, Modena, Padova, and Torino, ItalySee the 6 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07322003, who can take part
Where in Italy
- University of Campania "Luigi Vanvitelli"Caserta, ItalyTaking people
- Centro Clinico NEMO Fondazione Serena Onlus - ASST Niguarda HospitalMilan, ItalyTaking people
- Istituto Auxologico Italiano Ospedale San LucaMilan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- University of PadovaPadova, ItalyTaking people
- University of TorinoTorino, ItalyTaking 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
- Prilenia
- Trial code
- NCT07322003
- Record updated
- 27 October 2026
- Original description
The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:Read 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
The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:
Does pridopidine slow disease progression of ALS?
Researchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.
Participants will:
Take pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.
Visit the clinic once every 1-3 months for checkups and tests
Inclusion: 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.
Exclusion: Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides; 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; Presence of tracheostomy or permanent assisted ventilation; Confirmed mutation in the SOD1, FUS or C9orf72 gene; Pregnancy.