RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Pridopidine for Amyotrophic Lateral Sclerosis

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.

Official registry: https://clinicaltrials.gov/study/NCT07322003 · Prilenia · enrollment listed as 500

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Pridopidine, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults.

They plan to enroll about 500 people at 56 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis

Interventions: Pridopidine, Placebo

Primary outcome (registry wording): Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
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

Who the registry excludes

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
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

Public study contact (from the registry)

Prilenia Medical Information

857-574-5755

MedInfo@prilenia.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

56 listed

Barrow Neurological Institute — Phoenix, Arizona (recruiting)
California Pacific Medical Center — San Francisco, California (recruiting)
University of Colorado CU Anschutz Neurology — Aurora, Colorado (recruiting)
Mayo Clinic — Jacksonville, Florida (recruiting)
University of South Florida — Tampa, Florida (recruiting)
Emory University — Atlanta, Georgia (recruiting)
Northwestern University — Chicago, Illinois (recruiting)
University of Kansas — Fairway, Kansas (recruiting)
Johns Hopkins University — Baltimore, Maryland (recruiting)
Sean M. Healey & AMG Center for ALS — Boston, Massachusetts (recruiting)
Washington University — St Louis, Missouri (recruiting)
Somnos Clinical Research — Lincoln, Nebraska (recruiting)

+ 38 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07322003 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07322003?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07322003?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary