AMX0035 for Progressive Supranuclear Palsy
(ORION Trial)
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that AMX0035 for Progressive Supranuclear Palsy is an effective drug?
The available research does not provide any data supporting the effectiveness of AMX0035 for Progressive Supranuclear Palsy. The studies mentioned focus on other treatments like davunetide, tideglusib, RS-86, and riluzole, none of which showed significant benefits for this condition. Therefore, there is no evidence from the provided information that AMX0035 is effective for treating Progressive Supranuclear Palsy.12345
What safety data is available for AMX0035 (Relyvrio/Albrioza) in treating neurodegenerative diseases?
AMX0035, also known as Relyvrio or Albrioza, is a coformulation of sodium phenylbutyrate and ursodoxicoltaurine. It has been approved for the treatment of amyotrophic lateral sclerosis (ALS) based on phase II trial data, which showed it slowed ALS progression compared to placebo. However, it poses risks for patients sensitive to salt intake and those with pancreatic, intestinal, and enterohepatic circulation disorders. No phase 3 clinical trial data is available yet.678910
Is AMX0035 safe for humans?
Is the drug AMX0035 a promising treatment for Progressive Supranuclear Palsy?
How does the drug AMX0035 differ from other treatments for progressive supranuclear palsy?
AMX0035 is unique because it combines sodium phenylbutyrate and ursodoxicoltaurine, which are thought to protect nerve cells, unlike other treatments that have not shown significant benefits in PSP. This combination is being explored for its potential to modify disease progression, which is different from existing treatments that primarily focus on symptom management.1231112
Research Team
Study Director
Principal Investigator
Amylyx Pharmaceuticals
Eligibility Criteria
This trial is for people aged 40-80 with Progressive Supranuclear Palsy (PSP) who've had symptoms for less than 5 years. They must be able to walk with little help, score at least 24 on a mental state exam, and not live in skilled nursing or dementia care facilities.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AMX0035 or placebo for 52 weeks in a double-blind, placebo-controlled phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of AMX0035 treatment long-term
Treatment Details
Interventions
- AMX0035
- Placebo
AMX0035 is already approved in United States, Canada for the following indications:
- Amyotrophic Lateral Sclerosis
- Amyotrophic Lateral Sclerosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amylyx Pharmaceuticals Inc.
Lead Sponsor