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AMX0035 for Amyotrophic Lateral Sclerosis

Phase 2 & 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
Men must agree to practice contraception for the duration of the study and 3 months after last dose of study drug. Men must not plan to father a child or provide sperm for donation for the duration of the study and 3 months after last dose of study drug
Any patient who has completed follow-up in an Amylyx sponsored trial of AMX0035 for the treatment of ALS will be eligible to enroll into this Protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 1 year
Awards & highlights

Study Summary

This trial is for people who have already tried AMX0035 for ALS and want to continue treatment.

Eligible Conditions
  • Amyotrophic Lateral Sclerosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment emergent Adverse Events

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%
Dry mouth
3%
Dysphagia
3%
Insomnia
2%
Respiratory failure
2%
Neck pain
2%
Oedema peripheral
1%
Cellulitis
1%
Diverticulitis
1%
Pneumonia
1%
Bacteraemia
1%
Skull fracture
1%
Nephrolithiasis
1%
Respiratory arrest
1%
Vision blurred
1%
Pneumoperitoneum
1%
Subdural haematoma
1%
Stoma site haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AMX0035

Trial Design

1Treatment groups
Experimental Treatment
Group I: AMX-0035 long term treatment extensionExperimental Treatment1 Intervention
AMX0035 administered twice daily p.o.
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
2,153 Total Patients Enrolled
5 Trials studying Amyotrophic Lateral Sclerosis
1,432 Patients Enrolled for Amyotrophic Lateral Sclerosis
Machelle Manual, PhDStudy DirectorAmylyx Pharmaceuticals Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

how many different medical facilities are testing this new treatment?

"If you are interested in participating in this trial, know that recruitment is happening at 5 different medical sites. These include locations in Worcester, Boston and Ann Arbor as well as 2 other unlisted cities. For your convenience, try to choose the closest site to reduce travel times."

Answered by AI
~6 spots leftby Mar 2025