AMX0035 for ALS (Phoenix Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amylyx Pharmaceuticals Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The Phoenix Trial is a randomized double blind placebo controlled Phase III trial to evaluate the safety and efficacy of AMX0035 for treatment of ALS

Eligibility Criteria

This trial is for adults diagnosed with ALS within the last 2 years who can consent and follow study procedures. They must use birth control during the study and not plan to conceive. Excluded are pregnant or breastfeeding women, those with severe medical conditions, on salt restriction, enrolled in other trials, using prohibited meds, or have specific health issues like low lung capacity or poor kidney function.

Inclusion Criteria

My first ALS symptoms appeared less than 2 years ago.

I have been diagnosed with ALS.

Exclusion Criteria

I have a tracheostomy or use a ventilator to help me breathe.

I have severe heart failure.

I do not have any mental health or substance issues that would prevent me from understanding this study.

I have had cellular or gene therapies for ALS.

My liver tests are more than 5 times the normal limit.

Treatment Details

The Phoenix Trial is testing AMX0035 against a placebo to see if it's safe and effective for treating ALS. This Phase III trial randomly assigns participants to either receive AMX0035 or a placebo without them knowing which one they're getting (double-blind).

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AMX0035Experimental Treatment1 Intervention

Placebo administered by mouth or via feeding tube for 48 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating

Group II: PlaceboPlacebo Group1 Intervention

Placebo administered by mouth or via feeding tube for 48 weeks: once daily for first 3 weeks and then twice daily for remainder of study if participant tolerating

AMX0035 is already approved in United States, Canada for the following indications:

🇺🇸 Approved in United States as Relyvrio for: