๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-04

Pridopidine Phase 3 Study in Huntington's Disease (NCT07609108)

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Huntington's Disease (HD)

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Prilenia

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goal of this clinical trial is to learn if pridopidine can slow the clinical decline of Huntington's Disease (HD) in adult participants. It will also inform about the safety of pridopidine. The main questions the study aims to answer are: Does pridopidine slow the overall worsening of HD over 1 year? Does pridopidine slow the worsening of specific aspects of HD over 1 year, namely the clinical progression, the ability to perform daily life activities (functional capacity), the mind's ability to process information (cognition), working of the muscles (motor function), and quality of life? Researchers will compare the drug pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works better than placebo to treat HD. During the first year of the study, participants will have the same chance to receive either pridopidine or placebo. Participants will: Take 1 pridopidine or placebo capsule twice daily for 12 months. Visit the clinic 6 times within 1 year for checkups and tests. All participants who complete this 1-year placebo-controlled study period will roll over into an additional 2-year study period during which all participants will receive pridopidine treatment, including participants who had received placebo during the first year. During this additional 2-year treatment period participants will visit the clinic a total of 6 times for checkups and tests.

Who can join: Review the eligibility criteria below.

Location: The University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 23 Years to 65 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (66 Sites)

Showing the first 25 of 66 sites.

  • The University of Alabama at Birmingham โ€” Birmingham, Alabama
  • University of California, San Diego โ€” La Jolla, California
  • UCLA Medical Center โ€” Los Angeles, California
  • UC Davis Medical Center โ€” Sacramento, California
  • Georgetown University โ€” Washington D.C., District of Columbia
  • University of Miami-U Health Boca Raton โ€” Boca Raton, Florida
  • University of Florida (Norman Fixel Institute for Neurological Diseases) โ€” Gainesville, Florida
  • Northwestern University โ€” Chicago, Illinois
  • Rush University Medical Center โ€” Chicago, Illinois
  • University of Kansas Medical Center โ€” Kansas City, Kansas
  • Hereditary Neurological Disease Centre โ€” Wichita, Kansas
  • Johns Hopkins University โ€” Baltimore, Maryland
  • Massachusetts General Hospital โ€” Charlestown, Massachusetts
  • Struthers Parkinson's Center / Health Partners Institute โ€” Golden Valley, Minnesota
  • Columbia University โ€” New York, New York
  • Duke University โ€” Durham, North Carolina
  • University of Cincinnati โ€” Cincinnati, Ohio
  • Cleveland Clinic โ€” Cleveland, Ohio
  • The Ohio State University โ€” Columbus, Ohio
  • Oregon Health and Science University (OHSU) โ€” Portland, Oregon
  • Vanderbilt University Medical Center โ€” Nashville, Tennessee
  • UT Health, Houston, McGovern Medical School โ€” Houston, Texas
  • University of Vermont Medical Center โ€” Burlington, Vermont
  • EvergreenHealth Research Department โ€” Kirkland, Washington
  • University of Washington โ€” Seattle, Washington

๐Ÿ“ž Contact the Study Coordinator

Phone: 018575745755

Email: MedInfo@prilenia.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—