Summary

Eligibility
for people ages 40-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Details

AMX0035 is a fixed dose combination therapy designed to reduce neuronal death through blockade of key cellular death pathways originating in the endoplasmic reticulum (ER) and mitochondria. This clinical trial is designed to demonstrate that AMX0035 is safe and tolerable, and to assess its effect on disease progression as measured by the Progressive Supranuclear Palsy (PSP) Rating Scale (PSPRS) over a 52-week double-blind phase. The Phase 2b and Phase 3 study portions are planned to feature an identical design: a randomized, double-blind, placebo-controlled phase that is followed by an optional open-label extension (OLE) phase. The phase 3 portion of ORION may be initiated based on results of the phase 2b Interim Analysis and/or the Primary Analysis and the totality of data from the Phase 2b study portion.

Keywords

Progressive Supranuclear Palsy, PSP, Neurodegenerative Diseases, Atypical Parkinsonism, Steele-Richardson-Olszewski Syndrome, ORION, Amylyx, Paralysis, Parkinsonian Disorders, AMX0035

Eligibility

Locations

  • UCSF (UCSF)
    San Francisco California 94158 United States
  • Stanford Movement Disorder Center
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amylyx Pharmaceuticals Inc.
ID
NCT06122662
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 110 study participants
Last Updated