Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06122662 · ClinicalTrials.gov registry record · Phase 2
AMX0035 and Progressive Supranuclear Palsy
A Phase 2 study of Progressive Supranuclear Palsy and Neurodegenerative Diseases, sponsored by Amylyx Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 20
- Study locations
NCT06122662: Active Phase 2 study of Progressive Supranuclear Palsy and Neurodegenerative Diseases, sponsored by Amylyx Pharmaceuticals.
NCT06122662 is a Phase 2 study of Progressive Supranuclear Palsy and Neurodegenerative Diseases that is active but no longer recruiting, run by Amylyx Pharmaceuticals. The registered enrollment target is 110 participants, below the 446-participant average among 18 other Progressive Supranuclear Palsy trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06122662, a Phase 2 study of Progressive Supranuclear Palsy and Neurodegenerative Diseases, is active but no longer recruiting, sponsored by Amylyx Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Assess the impact of AMX0035 on disease progression as measured by the Progressive Supranuclear Palsy (PSP) Rating Scale (PSPRS); Total scores range from 0-96 with higher scores indicating more progressed disease
Conditions Studied
Interventions
- OTHER Placebo
- DRUG AMX0035
Study Locations (20)
California
- Parkinson's & Movement Disorder Institute - Fountain Valley
- University of Southern California - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Stanford Movement Disorder Center - Palo Alto
- University of California, San Francisco (UCSF) - San Francisco
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
- UF Health Dorothy Mangurian Neuroimaging Suite - Gainesville
- Mayo Clinic Florida - Jacksonville
Massachusetts
- Massachusetts General Hospital - Boston
- Lahey Hospital and Medical Center - Burlington
Arizona
- Mayo Clinic - Scottsdale
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- UC Health Anschutz Outpatient Pavilion Anschutz Medical Campus - Aurora
Georgia
- Augusta University - Augusta
Hawaii
- Parkinsons and Movement Disorder Center at the Queens Medical Center - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2023-12-21 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 2 |
What the registry record for NCT06122662 still lists
NCT06122662 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 18 other Progressive Supranuclear Palsy trials with a reported enrollment target (75% lower).
The record links to 4 conditions, with Progressive Supranuclear Palsy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06122662 names 20 study sites across 13 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06122662 about?
NCT06122662 is a clinical study titled "AMX0035 and Progressive Supranuclear Palsy". 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.
What is the current status of trial NCT06122662?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2023-12-21. Estimated completion is 2029-11-30.
What conditions does trial NCT06122662 study?
This clinical trial studies the following conditions: Progressive Supranuclear Palsy, Neurodegenerative Diseases, PSP, Atypical Parkinsonism.
What interventions are being tested in trial NCT06122662?
The interventions under investigation include: Placebo (OTHER), AMX0035 (DRUG).
Who is sponsoring clinical trial NCT06122662?
This trial is sponsored by Amylyx Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06122662 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Progressive Supranuclear Palsy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06122662's enrollment target sits among peer trials
110 13th of 18 higher than 6 of 18 other Progressive Supranuclear Palsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Progressive Supranuclear Palsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP)
ACTIVE NOT RECRUITING · Phase 2
-
Effects of Coenzyme Q10 in PSP and CBD
COMPLETED · Phase 2
-
Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy
COMPLETED · Phase 2
-
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
RECRUITING
-
Gait Analysis in Neurological Disease
RECRUITING
-
A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01530373 · 110 participants · Phase 2
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
- NCT02379377 · 110 participants · Phase 1
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
- NCT02411773 · 110 participants · Phase 1
Sympatholysis in Chronic Kidney Disease
- NCT03190941 · 110 participants · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI