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AMX0035 for ALS (Phoenix Trial)
Phase 3
Waitlist Available
Research Sponsored by Amylyx Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Time since onset of first symptom of ALS should be <24 months prior to randomization
Diagnosis of ALS (definite or clinically probable)
Must not have
Presence of tracheostomy or permanent assisted ventilation (PAV)
History of Class III/IV heart failure (per New York Heart Association - NYHA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years from lpi
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new drug to see if it is safe and effective for treating ALS.
Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
While specific side effects of AMX0035 aren't listed here, common clinical trial risks may include allergic reactions to components of the treatment, gastrointestinal issues like nausea or diarrhea, fatigue, headaches, and potential liver enzyme elevations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My first ALS symptoms appeared less than 2 years ago.
Select...
I have been diagnosed with ALS.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a tracheostomy or use a ventilator to help me breathe.
Select...
I have severe heart failure.
Select...
I do not have any mental health or substance issues that would prevent me from understanding this study.
Select...
I have had cellular or gene therapies for ALS.
Select...
My liver tests are more than 5 times the normal limit.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years from lpi
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years from lpi
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Slope Change
Assess Long-Term Survival
Number of Participants With Adverse Events
+2 moreSide effects data
From 2019 Phase 2 trial • 137 Patients • NCT0312751428%
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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
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
1,139 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
922 Patients Enrolled for Amyotrophic Lateral Sclerosis
Amylyx Study DirectorStudy DirectorAmylyx Pharmaceuticals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: AMX0035
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
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