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RecruitingPhase 3

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Prilenia · with Ferrer Internacional S.A. · NCT07322003

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
500
US sites recruiting
18
Study start
February 1, 2026
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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

Being studied: Pridopidine; Placebo

Conditions: Amyotrophic Lateral Sclerosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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.

Key Exclusion Criteria

  • 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.

Recruiting US locations

  • Barrow Neurological Institute

    Phoenix, AZ 85013

    Site contact: Fulton.research@comminspirit.org

  • California Pacific Medical Center

    San Francisco, CA 94109

    Site contact: Christie Linh · clinicalresearch@sutterhealth.org

  • University of Colorado CU Anschutz Neurology

    Aurora, CO 80045

    Site contact: 303-724-4644 · neuroresearch@cuanschutz.edu

  • Mayo Clinic

    Jacksonville, FL 32224

  • University of South Florida

    Tampa, FL 33612

    Site contact: Jessica Shaw · (813) 974-9413 · jessshaw@usf.edu

  • Emory University

    Atlanta, GA 30322

    Site contact: Wanda Sanchez · 404-727-1273 · wanda.sanchez@emory.edu

  • Northwestern University

    Chicago, IL 60611

    Site contact: Candace James · candace.james@northwestern.edu

  • University of Kansas

    Fairway, KS 66205

    Site contact: nstaudenmier@kumc.edu

  • Johns Hopkins University

    Baltimore, MD 21205

    Site contact: Collen Kane · 410-502-6184 · Ckane13@jh.edu

  • Sean M. Healey & AMG Center for ALS

    Boston, MA 02114

    Site contact: Julia Stein · 617-726-1398 · mghpridopidinephase3healey@mgb.org

  • Washington University

    St Louis, MO 63110

    Site contact: 844-257-2273 · als@wustl.edu

  • Somnos Clinical Research

    Lincoln, NE 68506

    Site contact: 402-770-7403 · desi@somnos.com

  • Eleanor and Lou Gehrig ALS Center at Columbia University

    New York, NY 10032

    Site contact: Arish Jamil · aj3098@cumc.columbia.edu

  • Neuroscience Department at LKSM at Temple University

    Philadelphia, PA 19140

    Site contact: Kathleen Hatala · 215-707-4171 · Kathleen.hatala@tuhs.temple.edu

  • Texas Neurology

    Dallas, TX 75206

    Site contact: Amanda Pinal · 214-827-3610 · apinal@texasneurology.com

  • Baylor College of Medicine; McNair Medical Campus

    Houston, TX 77030

    Site contact: Jorge E. Zaragoza Zapiain · 713-798-0106 · Jorge.ZaragozaZapiain@bcm.edu

  • Swedish Medical Center

    Seattle, WA 98122

    Site contact: Laura Johnson · 206-320-7115 · Laura.Johnson3@Swedish.org

  • University of Washington

    Seattle, WA 98195

Study contacts (from the official record)

  • Prilenia Medical Information · 857-574-5755 · MedInfo@prilenia.com
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Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS (NCT07322003) | Bored Studies