Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Study acronym: PREVAiLS

StatusRecruiting

PhasePhase 3

SponsorPrilenia

Started2026-02-01

View on ClinicalTrials.gov ↗

Amendment history

2026-08-24

Study Status, Contacts/Locations v16

Study sitesdetails revised at 2 of 56 sites

2026-08-09

Study Status, Contacts/Locations v15

Study sitesdetails revised at 3 of 56 sites

2026-08-02

Study Status, Contacts/Locations v14

Study sitesdetails revised at 2 of 56 sites

2026-07-28

Study Status, Contacts/Locations v13

Trial sites expanded: 47 → 56 locations

Trial sites expanded: 44 → 47 locations

2026-07-27

Study Status, Contacts/Locations v12

Study sites44→47

2026-07-22

Study Status, Contacts/Locations v11

Trial sites expanded: 36 → 44 locations

2026-07-12

Study Status, Contacts/Locations v10

Study sites35→36

2026-07-07

Study Status, Contacts/Locations v9

Trial sites expanded: 32 → 35 locations

2026-07-01

Study Status, Contacts/Locations v8

Study sites30→32

2026-06-30

Study Status, Contacts/Locations v7

Study sites29→30

2026-06-25

Study Status, Contacts/Locations v6

Trial sites expanded: 24 → 28 locations

2026-06-23

Study Status, Contacts/Locations v5

Study sites24→28

2026-06-17

Study Status, Contacts/Locations v4

Trial sites expanded: 16 → 24 locations

2026-06-08

Study Status, Contacts/Locations v3

Trial sites expanded: 5 → 16 locations

2026-04-23

Study Status, Contacts/Locations v2

Study sites3→5

2026-02-25

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2026-01→confirmed 2026-02-01

Study sites0→3

2026-01-05

Original filing

Prilenia

2 trials monitored

See all monitored trials

ALS

384 trials monitored

See 17 trials at risk

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

Trial Details

NCT Number	NCT07322003
Lead Sponsor	Prilenia Collaborators: Ferrer Internacional S.A.
Conditions	Amyotrophic Lateral Sclerosis
Enrollment	500 participants
Start Date	2026-02-01
Primary Completion	2028-03 (estimated)
Study Completion	2029-03 (estimated)
Updated on ClinicalTrials.gov	2026-09-22