Recruiting
Phase 3

Pridopidine

Sponsor:

Prilenia

Code:

NCT07322003

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pridopidine

Placebo

Study Details

Brief summary:

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

Amyotrophic Lateral Sclerosis

Study ID

NCT07322003

Start date

Feb 1, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pridopidine

Pridopidine hard gelatin capsules of 45 mg strength. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally. Total daily dose of 90 mg.

placebo comparator: Placebo

Placebo hard gelatin capsules. During titration period 1 capsule taken orally in the morning for 2 weeks. During the main treatment period, 1 capsule in the morning and 1 capsule in the afternoon taken orally.

Interventions

Pridopidine

Pridopidine hard gelatin capsule.

Placebo

Placebo hard gelatin capsule.

Primary outcome measure

  • Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality [ Time Frame: Baseline to Week 48 ]

Central Contacts and Locations

Central contacts

Prilenia Medical Information

857-574-5755MedInfo@prilenia.com

Locations

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Fulton.research@comminspirit.org

California Pacific Medical Center

Recruiting

San Francisco, California, United States, 94109

Contacts

Christie Linh

clinicalresearch@sutterhealth.org

University of Colorado CU Anschutz Neurology

Recruiting

Aurora, Colorado, United States, 80045

Contacts

303-724-4644neuroresearch@cuanschutz.edu

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

Contacts

Jessica Shaw

(813) 974-9413jessshaw@usf.edu

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Wanda Sanchez

404-727-1273wanda.sanchez@emory.edu

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Candace James

candace.james@northwestern.edu

University of Kansas

Recruiting

Fairway, Kansas, United States, 66205

Contacts

nstaudenmier@kumc.edu

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Collen Kane

410-502-6184Ckane13@jh.edu

Sean M. Healey & AMG Center for ALS

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Julia Stein

617-726-1398mghpridopidinephase3healey@mgb.org

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

844-257-2273als@wustl.edu

Somnos Clinical Research

Recruiting

Lincoln, Nebraska, United States, 68506

Contacts

402-770-7403desi@somnos.com

wendy@somnos.com

Eleanor and Lou Gehrig ALS Center at Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Arish Jamil

aj3098@cumc.columbia.edu

Neuroscience Department at LKSM at Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Kathleen Hatala

215-707-4171Kathleen.hatala@tuhs.temple.edu

Christine Barr

215-707-5440Christine.barr@tuhs.temple.edu

Texas Neurology

Recruiting

Dallas, Texas, United States, 75206

Contacts

Amanda Pinal

214-827-3610apinal@texasneurology.com

Baylor College of Medicine; McNair Medical Campus

Recruiting

Houston, Texas, United States, 77030

Contacts

Jorge E. Zaragoza Zapiain

713-798-0106Jorge.ZaragozaZapiain@bcm.edu

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Laura Johnson

206-320-7115Laura.Johnson3@Swedish.org

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Genge Partners

Recruiting

Montreal, Quebec, Canada, H4P 2N2

Contacts

KMunoz@gengepartners.com

University of Alberta

Recruiting

Edmonton, Canada

More Information

Sponsor

Prilenia

Last update posted

Aug 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by Prilenia on 2026-08-25.