Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

What this study 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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• California Pacific Medical Center, San Francisco, California, United States
• Mayo Clinic, Jacksonville, Florida, United States
• University of South Florida, Tampa, Florida, United States
• Emory University, Atlanta, Georgia, United States
• Northwestern University, Chicago, Illinois, United States
• University of Kansas, Fairway, Kansas, United States
• Sean M. Healey & AMG Center for ALS, Boston, Massachusetts, United States
• Washington University, St Louis, Missouri, United States
• Somnos Clinical Research, Lincoln, Nebraska, United States
• Eleanor and Lou Gehrig ALS Center at Columbia University, New York, New York, United States
• Neuroscience Department at LKSM at Temple University, Philadelphia, Pennsylvania, United States
• Texas Neurology, Dallas, Texas, United States

+ 23 more sites.

Who to contact

Prilenia Medical Information · 857-574-5755 · MedInfo@prilenia.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07322003.