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AMX0035 for Progressive Supranuclear Palsy (ORION Trial)

Phase 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

Awards & highlights

ORION Trial 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.Check my eligibility

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.See study design

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.

ORION 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.

ORION Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in total (28-item) Progressive Supranuclear Palsy Rating Scale (PSPRS) Score

Secondary outcome measures

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

Abdominal pain

Decreased appetite

Fatigue

Laceration

Back pain

Abdominal discomfort

Muscle spasms

Arthralgia

Musculoskeletal pain

Contusion

Urinary Tract Infection

Cough

Weight decreased

Asthenia

Rash

Aspartate aminotransferase increased

Musculoskeletal chest pain

Abdominal pain upper

Upper Respiratory Tract Infection

Alanine aminotransferase increased

Dysphagia

Dry mouth

Insomnia

Respiratory failure

Neck pain

Oedema peripheral

Pneumoperitoneum

Skull fracture

Bacteraemia

Cellulitis

Pneumonia

Diverticulitis

Nephrolithiasis

Respiratory arrest

Vision blurred

Subdural haematoma

Stoma site haemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

AMX0035

ORION 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 administered by mouth: twice daily for an additional 52 weeks

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Amylyx Pharmaceuticals Inc.Lead Sponsor

9 Previous Clinical Trials

1,581 Total Patients Enrolled

Study DirectorStudy DirectorAmylyx Pharmaceuticals

1,211 Previous Clinical Trials

488,672 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is eligibility open for this medical research?

"This clinical trial seeks to recruit 600 individuals with progressive supranuclear palsy, aged between 40 and 80 years old."

Answered by AI

What potential risks accompany the use of AMX0035?

"AMX0035 has the safety rating of 3, as there is ample evidence to suggest its efficacy and security. This evaluation comes from a Phase 3 trial, which provides robust data for us to assess the compound's risk profile."

Answered by AI

How many participants are being surveyed in this experiment?

"Yes, clinicaltrials.gov lists this trial as currently in recruitment mode; it was initially posted on November 15th 2023 and recently updated on the 21st of that same month. 600 participants are expected to enroll at two different locations."

Answered by AI

Is this clinical research open to elderly participants who are 85 or older?

"The lower age threshold for this trial is 40 years old and the upper limit is 80 years old, as detailed in the study's eligibility criteria."

Answered by AI

Are recruitment efforts for this research endeavor still ongoing?

"Affirmative. Per the info posted on clinicaltrials.gov, this investigation is actively recruiting participants from two different medical centres and has already received 600 applicants since its initial posting date of November 15th 2023 with its most recent update occurring on November 21st 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AMX0035 and Progressive Supranuclear Palsy

2023. "AMX0035 and Progressive Supranuclear Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06122662.

All > Progressive Supranuclear Palsy