Actively Recruiting
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
Led by Prilenia · Updated on 2026-04-24
500
Participants Needed
5
Research Sites
160 weeks
Total Duration
On this page
Sponsors
P
Prilenia
Lead Sponsor
F
Ferrer Internacional S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with definite or probable ALS using the El Escorial criteria
- Symptom onset within 18 months before screening
- Slow vital capacity (SVC) of 60% or greater of predicted
- TRICALS Risk Profile Calculator score between -6 and -2 at screening
- Able to swallow capsules
You will not qualify if you...
- Presence of tracheostomy or permanent assisted ventilation
- Clinically significant heart disease or certain arrhythmias, including uncontrolled atrial fibrillation or sustained ventricular tachycardia
- Left bundle branch block
- Unstable psychiatric disease, cognitive impairment, dementia, or substance abuse affecting consent or participation
- Clinically significant or unstable medical conditions other than ALS posing risk
- Use of medications that prolong QT interval
- Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides
- Confirmed mutation in SOD1, FUS, or C9orf72 genes
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Kansas
Fairway, Kansas, United States, 66205
Actively Recruiting
2
Sean M. Healey & AMG Center for ALS
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Somnos Clinical Research
Lincoln, Nebraska, United States, 68506
Actively Recruiting
4
Texas Neurology
Dallas, Texas, United States, 75206
Actively Recruiting
5
Genge Partners
Montreal, Quebec, Canada, H4P 2N2
Actively Recruiting
Research Team
E
Executive Director Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here