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AMX0035 and Progressive Supranuclear Palsy

NCT06122662 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2026-04-30

No results posted yet for this 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.

Conditions

Interventions

DRUG

AMX0035

Proprietary formulation of sodium phenylbutyrate and taurursodiol

OTHER

Placebo

Matching Placebo Comparator

Sponsors & Collaborators

  • Amylyx Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Amylyx Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-21
Primary Completion
2025-09-30
Completion
2025-10-21
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06122662 on ClinicalTrials.gov