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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
Awards & highlights

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.Check my eligibility
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).See study design
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 below
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My first ALS symptoms appeared less than 2 years ago.
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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.
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I do not have any mental health or substance issues that would prevent me from understanding this study.
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I have had cellular or gene therapies for ALS.
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My liver tests are more than 5 times the normal limit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Slope Change And Survival
Number of Participants With Adverse Events
Number of Participants in Each Group Able to Remain on Study Drug Until Planned Discontinuation
Secondary outcome measures
Assess Long-Term Survival
Decline in King's and MiToS Stages
Participant Health Status
+3 more

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
8%
Decreased appetite
8%
Abdominal pain
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%
Cellulitis
1%
Pneumoperitoneum
1%
Pneumonia
1%
Skull fracture
1%
Diverticulitis
1%
Bacteraemia
1%
Nephrolithiasis
1%
Respiratory arrest
1%
Vision blurred
1%
Subdural haematoma
1%
Stoma site haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AMX0035

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
9 Previous Clinical Trials
1,581 Total Patients Enrolled
5 Trials studying Amyotrophic Lateral Sclerosis
860 Patients Enrolled for Amyotrophic Lateral Sclerosis

Media Library

AMX0035 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05021536 — Phase 3
Amyotrophic Lateral Sclerosis Research Study Groups: AMX0035, Placebo
Amyotrophic Lateral Sclerosis Clinical Trial 2023: AMX0035 Highlights & Side Effects. Trial Name: NCT05021536 — Phase 3
AMX0035 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05021536 — Phase 3
~164 spots leftby Jul 2025
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