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Taking people in ItalyPhase 3

Pridopidine for adults with amyotrophic lateral sclerosis (ALS)

Tests pridopidine against a placebo in adults with amyotrophic lateral sclerosis.

Key facts

Who runs it
Ferrer Internacional S.A.
Where
Milan, Modena, Naples, Padova, and Turin, ItalySee the 6 sitesAlso in 8 other countries, 24 sites
Registry title
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS (PREVAiLS)
Status
Recruiting
Phase
Phase 3
People taking part
420 people, planned
Started
12 May 2026
Expected to end
30 Apr 2029
Type of study
Interventional
Record updated
14 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 80 with definite or probable ALS (amyotrophic lateral sclerosis), with symptoms that began 18 months ago or less.

Age
18 to 80 years, both included
Sex
All sexes can join.
Disease stage
Definite ALS or Probable ALS by the El Escorial criteria. Symptoms began 18 months ago or less. SVC (a breathing test) at least 60% predicted.
Biomarker or test result
A TRICALS Risk Profile Calculator score (based on the ENCALS survival prediction model) from -6 to -2, both included, at screening.

Main reasons for not taking part

  • A tracheostomy or permanent assisted ventilation
  • Clinically significant heart disease, a clinically significant history of arrhythmia, or a left bundle branch block
  • Unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would affect giving informed consent
  • Another clinically significant or unstable medical condition that may pose a meaningful risk to the participant or to finishing the study

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Italy

Also in 8 other countries, 24 sites

  • Centro Clinico NemoMilan, ItalyTaking people
  • Istituto Auxologico ItalianoMilan, ItalyTaking people
  • Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
  • Azienda Ospedaliera di PadovaPadova, ItalyTaking people
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people

About the trial

What the trial wants to find out

To evaluate the effect of pridopidine on disease progression in participants with ALS

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants with Amyotrophic Lateral Sclerosis
Plain-language title
Pridopidine for adults with amyotrophic lateral sclerosis (ALS)Generated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
14 May 2026