AMX0035 for ALS
(Phoenix Trial)
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
Research Team
Amylyx Study Director
Principal Investigator
Amylyx Pharmaceuticals
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AMX0035 or placebo for 48 weeks to evaluate safety and efficacy in ALS treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Long-term survival will be monitored by assessing all-cause mortality
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