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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to week 51
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective for treating people with ALS.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose up to week 51
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to week 51
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Number of Participants with Abnormalities in Vital Signs, Clinical Laboratory Assessments, Physical and Neurological Examinations, Electrocardiograms (ECGs)
Secondary outcome measures
Area Under the Drug Concentration-Time Curve (AUC)
Change From Baseline in AP-101 Levels in the Cerebrospinal Fluid (CSF) up to Week 24
Change From Baseline in Neurofilament Light Chain and Phospho-Neurofilament Heavy Chain Levels in Plasma up to Week 51
+3 moreTrial 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.
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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
1,211 Previous Clinical Trials
489,290 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
18 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has AP-101 received authorization from the FDA?
"Our team has assigned AP-101 a score of 2 on the safety scale, as there is some evidence for safe usage but no data supporting its efficacy."
Answered by AI
What is the target enrollment for this medical experiment?
"Affirmative, the information available on clinicaltrials.gov attests to this study’s continued recruitment efforts. It was initially published on September 2nd 2021 and underwent its latest revision on August 12th 2022; 63 participants are needed from 6 designated sites."
Answered by AI
How widely is this trial being implemented across medical centers?
"This trial is now accepting participants in 6 various locations, including New york City, La Jolla and Toronto. It may be beneficial to select the nearest clinic for potential enrollees so as to avoid extensive travel arrangements."
Answered by AI
Is this experiment open for enrolment?
"The clinical trial is enrolling participants, consistent with the information available on clinicialtrials.gov. The study was initiated on September 2nd 2021 and underwent its most recent revision in August 2022."
Answered by AI
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