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Unknown
LAM-002A for ALS
Phase 2
Waitlist Available
Led By Suma Babu, M.D.
Research Sponsored by AI Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of C9ORF72-associated ALS with documentation of a clinical genetic test demonstrating the presence of a pathogenic repeat expansion in C9ORF72
Vital Capacity greater than and equal to 50% of predicted at the time of the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to treat ALS that is caused by the C9ORF72 gene.
Who is the study for?
Adults with C9ORF72-associated ALS who can consent, swallow capsules, and have a vital capacity ≥50% of predicted. They must not be on certain medications or treatments for ALS, have unstable medical conditions besides ALS, active cancer (with exceptions), or severe liver/kidney issues. Men and women must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing LAM-002A's safety and biological effect in C9ALS patients compared to a placebo. Participants will receive either the drug or placebo while being monitored for tolerance and any changes in their condition.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be closely observed for any adverse reactions related to LAM-002A or the placebo during the trial period.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have ALS linked to a C9ORF72 gene mutation.
Select...
My lung function is at least half of what is expected for someone my age and size.
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I am 18 years old or older.
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I can safely swallow capsules.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CSF Pharmacokinetics of LAM-002A
Plasma Pharmacokinetics of LAM-002A
Safety of LAM-002A: occurrence of TEAEs
+1 moreSecondary outcome measures
Changes in biomarkers
Tolerability of LAM-002A: completion of open-label study treatment
Other outcome measures
Changes in ALS-CBS
Changes in ALSFRS-R
Changes in Vital Capacity
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LAM-002AExperimental Treatment1 Intervention
LAM-002A will be administered orally in five 25 mg capsules twice a day (250 mg total daily dose).
Group II: PlaceboPlacebo Group1 Intervention
Placebo matching LAM-002A will be administered orally in 5 capsules twice a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LAM-002A
2015
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
AI Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
262 Total Patients Enrolled
OrphAI TherapeuticsLead Sponsor
6 Previous Clinical Trials
262 Total Patients Enrolled
Suma Babu, M.D.Principal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a brain disorder not caused by C9ORF72 gene changes.I do not have any unstable health conditions that could put me at risk.Your liver tests show that your liver may not be working properly.My kidneys are not working as well as they should.My previous health issue hasn't improved or enough time hasn't passed for a retest.I have ALS linked to a C9ORF72 gene mutation.I am not on edaravone or have finished at least one cycle and plan to continue.I am currently on medication to suppress my immune system.I am a male and unwilling to use contraception.You must have been diagnosed with ALS using specific guidelines called the revised El Escorial criteria.You have a mental health condition that is not well controlled or you have problems with substance abuse.My lung function is at least half of what is expected for someone my age and size.I am not taking medication that strongly affects liver enzymes.I do not have stomach or intestine problems that could affect how a drug works or is studied.You have used experimental treatments for ALS within a certain period of time.I have cancer or a history of it, with some exceptions.I have been on a stable dose of riluzole for over 30 days, or I am not taking it.I am 18 years old or older.I can safely swallow capsules.You have received experimental gene therapies for ALS.I have had a solid organ transplant.I am taking medication that is a strong influencer on the CYP2C9 enzyme.I cannot have a lumbar puncture due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: LAM-002A
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.
Can you give me a number of how many places this trial is happening?
"Presently, this trial is being conducted at Holy Cross Hospital in Fort Lauderdale, Florida; Johns Hopkins University School of Medicine in Baltimore, Maryland; and Massachusetts General Hospital in Boston, Massachusetts. There are 4 other locations where the study is also taking place."
Answered by AI
How does LAM-002A's safety profile compare to other drugs on the market?
"LAM-002A falls into Phase 2 of clinical trials, which means that while there is safety data available, none exists yet to support efficacy."
Answered by AI
Are there any current vacancies for trial participants?
"From what is available on clinicaltrials.gov, it appears that this particular trial is not currently looking for patients to participate. The original posting was on December 23rd, 2021 and the most recent edit was done on August 10th, 2022. Although 566 other trials are actively recruiting participants."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Holy Cross Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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