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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have possible, clinically probable, clinically probable-laboratory supported or definite familial or sporadic ALS in accordance with the El-Escorial criteria or who have a diagnosis of ALS as defined by the Gold Coast Criteria; progressive motor impairment documented by history or repeated clinical examination, preceded by normal motor development, and presence of upper and lower motor neuron dysfunction in at least 1 body region or lower motor neuron dysfunction in at least 2 body regions and investigations excluding other conditions
In familial ALS participants, a confirmed pathogenic superoxide dismutase 1 (SOD1) mutation
Must not have
Have undergone stem cell therapy
Are on nasal intermittent positive pressure ventilation (NIPPV) >4 hours per day for the treatment of ALS related symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of the study up to week 51
Awards & highlights
Summary
This trial is testing a new treatment called AP-101 to see if it is safe and well-tolerated. It focuses on people with familial and sporadic ALS, a condition that affects nerve cells and muscle control. Researchers want to understand how AP-101 moves through the body and its effects on ALS symptoms.
Who is the study for?
This trial is for adults with familial or sporadic ALS who meet specific clinical criteria, including normal lab results and a slow vital capacity of at least 50% predicted values. Participants must not be pregnant, nursing, or have other neuromuscular conditions. They should not have had certain treatments like stem cell therapy recently and must agree to use contraception.
What is being tested?
The study tests the safety and effects of AP-101 on people with ALS compared to a placebo. It looks at how the body processes the drug (pharmacokinetics) and its impact on disease markers (pharmacodynamics). Some participants may continue in an open-label extension based on investigator judgment.
What are the potential side effects?
While specific side effects are not listed here, generally this type of trial will monitor for any adverse reactions ranging from mild symptoms like headaches or nausea to more serious issues affecting organ function which could arise from taking AP-101.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with ALS based on specific criteria and show progressive motor impairment.
Select...
I have a confirmed SOD1 mutation linked to my familial ALS.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have undergone stem cell therapy.
Select...
I use a breathing machine for my ALS symptoms more than 4 hours daily.
Select...
I do not have severe heart, blood, kidney, brain diseases, lung problems, or mental health issues.
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I have had a tracheostomy for my ALS symptoms.
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I have conditions that cause muscle weakness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of the study up to week 51
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of the study up to week 51
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AP-101Experimental Treatment1 Intervention
AP-101 is administered by IV.
Group II: PlaceboPlacebo Group1 Intervention
Placebo is administered by IV.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Amyotrophic Lateral Sclerosis (ALS) include riluzole, edaravone, and sodium phenylbutyrate-taurursodiol. Riluzole works by inhibiting glutamate release, which helps reduce excitotoxicity—a process that damages neurons in ALS.
Edaravone acts as an antioxidant, reducing oxidative stress and protecting motor neurons from damage. Sodium phenylbutyrate-taurursodiol combines two compounds that reduce neuronal cell death by targeting mitochondrial and endoplasmic reticulum stress pathways.
These mechanisms are crucial for ALS patients as they aim to slow disease progression, preserve motor function, and improve quality of life.
Inflammation, immunity, and amyotrophic lateral sclerosis: II. immune-modulating therapies.Translating biological findings into new treatment strategies for amyotrophic lateral sclerosis (ALS).
Inflammation, immunity, and amyotrophic lateral sclerosis: II. immune-modulating therapies.Translating biological findings into new treatment strategies for amyotrophic lateral sclerosis (ALS).
Find a Location
Who is running the clinical trial?
AL-S PharmaLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
18 Patients Enrolled for Amyotrophic Lateral Sclerosis
Study DirectorStudy DirectorAL-S Pharma SA
1,260 Previous Clinical Trials
503,299 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
82 Patients Enrolled for Amyotrophic Lateral Sclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone stem cell therapy.I have not had SOD1 targeting treatment in the last 6 months.I have been diagnosed with ALS based on specific criteria and show progressive motor impairment.I don't use BiPAP/PAV for ALS symptoms more than 4 hours. I may use CPAP for other conditions.I am using birth control as required.I use a breathing machine for my ALS symptoms more than 4 hours daily.I do not have severe heart, blood, kidney, brain diseases, lung problems, or mental health issues.I have been taking the same dose of riluzole for a while.I have a confirmed SOD1 mutation linked to my familial ALS.Your laboratory test results should be within the normal range, or if they are slightly outside the normal range, they should not be considered medically concerning by the doctor.Your slow vital capacity (SVC) should be at least 50% of what is expected for someone of your age, gender, and size. If it's less than 50%, the doctor might still allow you to join the study.I have had a tracheostomy for my ALS symptoms.I have conditions that cause muscle weakness.I have completed 2 cycles of edaravone and will keep the same dose during the study.My symptoms started less than 2 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: AP-101
Awards:
This trial has 0 awards, including: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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