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AMX0035 for ALS (Phoenix Trial)
Phoenix Trial Summary
This trial is testing a new drug to see if it is safe and effective for treating ALS.
Phoenix Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPhoenix Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 137 Patients • NCT03127514Phoenix Trial Design
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Who is running the clinical trial?
Media Library
- I can and will follow all trial procedures and visit requirements.I haven't taken PB or taurursodiol in the last 30 days.My kidney function is low, with an eGFR under 60.You have a history of being allergic to phenyl butyrate or bile salts.I am on a strict low-salt diet for health reasons.My first ALS symptoms appeared less than 2 years ago.I have been diagnosed with ALS.I have not taken any prohibited medications in the last 30 days.I have a tracheostomy or use a ventilator to help me breathe.I can understand and agree to the study's details.I agree to use contraception during the study and for 3 months after.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 been on a stable dose of riluzole and/or edaravone for the required time.I am 18 years old or older.I do not have severe liver or bile duct problems.I have had cellular or gene therapies for ALS.Your slow vital capacity (SVC) is less than 55%.You have a device called a Diaphragm Pacing System (DPS) implanted in your body.My liver tests are more than 5 times the normal limit.
- Group 1: AMX0035
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people are total participating in this test?
"600 participants that meet the necessary requirements are needed for this study to happen. The sponsor, Amylyx Pharmaceuticals Inc., plans to host the trial at Providence St. Luke's Rehabilitation Medical Center in Spokane, Washington and University of Wisconsin-Madison in Madison, Wisconsin among other locations."
What is the purpose of this clinical trial?
"According to the clinical trial sponsor, Amylyx Pharmaceuticals Inc., the primary objective of this study is to measure theAmyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Slope Change And Survival over a 48 week period. Additionally, this study will also be secondary outcomes including Long-Term Survival and Rate of Decline in Slow Vital Capacity (SVC). Quality of Life (QOL) for participants will also be measured using the 40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) patient-reported outcome (PRO)."
Are patients being recruited for this research project at the moment?
"The trial, which was first advertised on clinicaltrials.gov on October 28th, 2021 is still recruiting participants according to the most recent update from October 5th, 2022."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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