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Pridopidine for ALS

This study is testing a drug called pridopidine to see if it can help adults with amyotrophic lateral sclerosis (ALS) and if it is safe. Researchers want to know if pridopidine can slow down the progression of ALS. You would either receive pridopidine or a placebo (a pill with no medicine) for 48 weeks, and then everyone will take pridopidine for another 48 weeks. The main way they will measure success is by looking at changes in your ALS Functional Rating Scale (ALSFRS-R) score, which measures how ALS affects your daily activities, over 48 weeks. To join, you need to be between 18 and 80 years old, have definite or probable ALS diagnosed within the last 18 months, and have good lung function. The current recruitment status is unclear.

Study design
This is a Phase 3, randomized study with 500 planned participants. It is double-blind, meaning neither you nor your doctors will know if you are receiving pridopidine or the placebo during the first 48 weeks.
What's involved
You would take pridopidine or a placebo by mouth every day for 48 weeks, followed by pridopidine for another 48 weeks. You will visit the clinic once every 1-3 months for checkups and tests, for a total study duration of about 102 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured through Week 48, and the total study duration per participant is 102 weeks including screening and follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07322003

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Recruiting
PHASE3Ages 18–80InterventionalTreatment
Prilenia
~500 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:PridopidinePlacebo

At a glance

Recruiting sites
53 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality
Measured over Baseline to Week 48

Conditions

Amyotrophic Lateral Sclerosis

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Amyotrophic Lateral Sclerosis

NCT07322003

Where you'd take part

This study runs at 55 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • ALS Clinic Bonn University

    Bonn, Germanystudy coordinator listed

    Recruiting

  • ALS outpatient department at Charité - university medicine Berlin

    Berlin, Germanystudy coordinator listed

    Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizonastudy coordinator listed

    Recruiting

  • Baylor College of Medicine; McNair Medical Campus

    Houston, Texasstudy coordinator listed

    Recruiting

  • California Pacific Medical Center

    San Francisco, Californiastudy coordinator listed

    Recruiting

  • Centre Hospitalier Universitaire de Nice

    Nice, Francestudy coordinator listed

    Recruiting

  • Centrum Medyczne Neuromed

    Bydgoszcz, Polandstudy coordinator listed

    Recruiting

  • City Clinic Research Sp. z o.o.

    Warsaw, Polandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Prilenia Medical Information
[email protected]
857-574-5755
Email the study team

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Eligibility criteria

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

Presence of tracheostomy or permanent assisted ventilation.
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.
Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.
Confirmed mutation in the SOD1, FUS or C9orf72 gene.
Pregnancy.

What this trial measures

  • Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortalityBaseline to Week 48

    The ALSFRS-R encompasses 12 questions grouped into 4 domains to assess bulbar symptoms, limb and trunk functionality, respiratory symptoms, and the need for percutaneous endoscopic gastrostomy (PEG), non-invasive ventilation, or tracheostomy with invasive ventilation. Each function is scored from 0 (no ability) to 4 (normal), with a minimum total score of 0 and maximum total score of 48. Higher scores indicate better functioning.