๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-08-09

Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment (NCT05021536)

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Amylyx Pharmaceuticals Inc.

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

The Phoenix Trial is a randomized double blind placebo controlled Phase III trial to evaluate the safety and efficacy of AMX0035 for treatment of ALS

Who can join: Review the eligibility criteria below.

Location: Barrow Neurological Institute โ€” Phoenix, Arizona

Age range: 18 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 (69 Sites)

Showing the first 25 of 69 sites.

  • Barrow Neurological Institute โ€” Phoenix, Arizona
  • University of Southern California โ€” Los Angeles, California
  • University of California Irvine โ€” Orange, California
  • California Pacific Medical Center Research Institute โ€” San Francisco, California
  • University of Colorado โ€” Aurora, Colorado
  • University of Florida โ€” Gainesville, Florida
  • University of South Florida โ€” Tampa, Florida
  • Emory University โ€” Atlanta, Georgia
  • Augusta University Neuroscience Center โ€” Augusta, Georgia
  • Northwestern University โ€” Chicago, Illinois
  • Johns Hopkins University School of Medicine Outpatient Center โ€” Baltimore, Maryland
  • Healey & AMG Center for ALS Research at Massachusetts General Hospital โ€” Boston, Massachusetts
  • University of Massachusetts โ€” Worcester, Massachusetts
  • Hennepin Healthcare Research Institute โ€” Minneapolis, Minnesota
  • Washington University School of Medicine โ€” St Louis, Missouri
  • Somnos Clinical Research โ€” Lincoln, Nebraska
  • Rutgers University โ€” New Brunswick, New Jersey
  • Columbia University โ€” New York, New York
  • University of North Carolina at Chapel Hill โ€” Chapel Hill, North Carolina
  • Wake Forest University Health Sciences โ€” Winston-Salem, North Carolina
  • The Ohio State University โ€” Columbus, Ohio
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • Lewis Katz School of Medicine at Temple University โ€” Philadelphia, Pennsylvania
  • Austin Neuromuscular Center โ€” Austin, Texas
  • Texas Neurology โ€” Dallas, Texas

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. Review the official NIH record below to find the coordinating site.
  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†—