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AMX0035 for Progressive Supranuclear Palsy (ORION Trial)

Phase 2 & 3
Recruiting
Research Sponsored by Amylyx Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to walk independently or with minimal assistance
Male or female 40 to 80 years of age, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks

Summary

This trial will test the safety & effectiveness of a potential new treatment for Progressive Supranuclear Palsy (PSP). It will be done in two phases: a randomized blind trial & an optional open-label extension.

Who is the study for?
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.
What is being tested?
The ORION Trial tests the effectiveness and safety of AMX0035 against a placebo in PSP patients. It starts with a phase where participants are randomly assigned to get either AMX0035 or placebo without knowing which one they receive.
What are the potential side effects?
While specific side effects of AMX0035 aren't listed here, common ones may include digestive issues, headaches, fatigue, and potential allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can walk on my own or with little help.
Select...
I am between 40 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in total (28-item) Progressive Supranuclear Palsy Rating Scale (PSPRS) Score
Secondary study objectives
Change in MDS-UPDRS Part II Score
Change in total (10-item) Progressive Supranuclear Palsy Rating Scale (PSPRS) Score
Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Side effects data

From 2019 Phase 2 trial • 137 Patients • NCT03127514
28%
Fall
21%
Diarrhoea
20%
Muscular weakness
18%
Nausea
15%
Headache
13%
Constipation
11%
Salivary hypersecretion
11%
Viral Upper Respiratory Tract Infection
10%
Dizziness
10%
Dyspnoea
8%
Abdominal pain
8%
Decreased appetite
8%
Fatigue
7%
Laceration
6%
Abdominal discomfort
6%
Back pain
6%
Muscle spasms
6%
Arthralgia
6%
Musculoskeletal pain
6%
Contusion
6%
Urinary Tract Infection
6%
Cough
6%
Weight decreased
6%
Asthenia
6%
Rash
4%
Aspartate aminotransferase increased
4%
Musculoskeletal chest pain
4%
Abdominal pain upper
4%
Upper Respiratory Tract Infection
4%
Alanine aminotransferase increased
3%
Dysphagia
3%
Dry mouth
3%
Insomnia
2%
Respiratory failure
2%
Neck pain
2%
Oedema peripheral
1%
Pneumoperitoneum
1%
Vision blurred
1%
Bacteraemia
1%
Cellulitis
1%
Pneumonia
1%
Diverticulitis
1%
Respiratory arrest
1%
Skull fracture
1%
Nephrolithiasis
1%
Subdural haematoma
1%
Stoma site haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AMX0035

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AMX0035Experimental Treatment1 Intervention
AMX0035 administered by mouth for 52 weeks: once daily for first 2 weeks and then twice daily for remainder of study For participants electing to continue into the open-label phase at Week 52; AMX0035 will be administered once daily for first 2 weeks and then twice daily for remainder of open-label phase
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered by mouth for 52 weeks: once daily for first 2 weeks and then twice daily for remainder of study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMX0035
2018
Completed Phase 3
~360

Find a Location

Who is running the clinical trial?

Amylyx Pharmaceuticals Inc.Lead Sponsor
10 Previous Clinical Trials
1,693 Total Patients Enrolled
Study DirectorStudy DirectorAmylyx Pharmaceuticals
1,277 Previous Clinical Trials
499,224 Total Patients Enrolled
~65 spots leftby Apr 2026
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