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Completed Phase 2Phase 3 Interventional

AMX0035 and Progressive Supranuclear Palsy

ClinicalTrials.gov ID: NCT06122662

Public ClinicalTrials.gov record NCT06122662. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 12:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2b/3 Study of the Safety and Efficacy of AMX0035 in Progressive Supranuclear Palsy (ORION)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A35-009 (ORION) is a Phase 2b/3 trial to evaluate the efficacy and safety of AMX0035 in participants with Progressive Supranuclear Palsy (PSP), consisting of randomized, double blind placebo controlled phases, followed by an optional open-label extension phase.

Study identification

NCT ID
NCT06122662
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Amylyx Pharmaceuticals Inc.
Industry
Enrollment
139 participants

Conditions and interventions

Eligibility (public fields only)

Age range
40 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 21, 2023 (Actual)
Primary completion
Sep 30, 2025 (Actual)
Completion
Oct 21, 2025 (Actual)
Last update posted
Apr 30, 2026

2023 – 2025

United States locations

U.S. sites
35
U.S. states
24
U.S. cities
34
Facility City State ZIP Site status
Mayo Clinic Scottsdale Arizona 85259 —
University of Arkansas for Medical Sciences Little Rock Arkansas 72205 —
Parkinson's & Movement Disorder Institute Fountain Valley California 92708 —
University of Southern California Los Angeles California 90033 —
Cedars Sinai Medical Center Los Angeles California 90048 —
Stanford Movement Disorder Center Palo Alto California 94304 —
University of California, San Francisco (UCSF) San Francisco California 94158 —
UC Health Anschutz Outpatient Pavilion Anschutz Medical Campus Aurora Colorado 80045 —
Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida 33486 —
UF Health Dorothy Mangurian Neuroimaging Suite Gainesville Florida 32608 —
Mayo Clinic Florida Jacksonville Florida 32224 —
Augusta University Augusta Georgia 30912 —
Parkinsons and Movement Disorder Center at the Queens Medical Center Honolulu Hawaii 96813 —
Northwestern University PD and Movement Disorders Center Chicago Illinois 60611 —
University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas 66160 —
University of Kentucky Medical Center Lexington Kentucky 40536-0274 —
Ochsner Medical Center New Orleans Louisiana 70121 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Lahey Hospital and Medical Center Burlington Massachusetts 01805 —
Quest Research Institute Farmington Hills Michigan 48334 —
University of Minnesota, CTSI Minneapolis Minnesota 55414 —
Mayo Clinic - Rochester Rochester Missouri 55905 —
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas Nevada 89106 —
University of Cincinnati Cincinnati Ohio 45219 —
The Cleveland Clinic Foundation Cleveland Ohio 44195 —
Oregon Health & Science University Portland Oregon 97239 —
Pennsylvania Hospital Philadelphia Pennsylvania 19107 —
Medical University of South Carolina (MUSC) Charleston South Carolina 29425 —
Veracity Neuroscience, LLC Memphis Tennessee 38157 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —
Kerwin Medical Center Dallas Texas 75231 —
Baylor College of Medicine Houston Texas 77030 —
Central Texas Neurology Consultants Round Rock Texas 78681 —
University of Utah Movement Disorders Center Salt Lake City Utah 84108 —
Virginia Commonwealth University Department of Neurology Richmond Virginia 23298-0059 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06122662, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 30, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06122662 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →