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L1-79 for Autism

Phase 2
Waitlist Available
Research Sponsored by Yamo Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow study medication whole and self-administer medication or have a caregiver administer medication
Must live with a parent/primary caregiver or spend specified time with them
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Study Summary

This trial will test if L1-79 is safe and works well in kids with ASD who have an IQ above 70 and who's symptoms are rated as 'severe' by a clinician.

Who is the study for?
This trial is for young people aged 12-21 with Autism Spectrum Disorder (ASD). They must have certain intelligence and severity scores, be able to swallow medication, and either live with a caregiver or spend significant time with one. Participants need to agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests the effectiveness of L1-79 on ASD in adolescents. It's a 12-week crossover study, meaning participants will receive both the treatment and placebo at different times during the trial to compare effects.See study design
What are the potential side effects?
While specific side effects are not listed here, generally such trials monitor for any negative reactions ranging from mild discomforts like headaches or nausea to more serious issues that could affect mood, behavior, or physical health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take pills by myself or have someone who can help me.
Select...
I live with my parent or primary caregiver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vineland Adaptive Behavior Scale, Third Edition (Vineland-3), Average of the Growth Scale Value (GSV) score of the three Socialization Subdomains (combined)
Secondary outcome measures
Brief Observation of Social Communication Change (BOSCC)
Caregiver Global Impression of Change of 3 Most Bothersome Symptoms of ASD (CGI-3P)
Child's Sleep Habits Questionnaire (CSHQ)
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: L1-79 200 mg or 300 mg CapsulesExperimental Treatment1 Intervention
1 capsule twice daily
Group II: Placebo CapsulesPlacebo Group1 Intervention
1 capsule twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L1-79
2016
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Yamo Pharmaceuticals LLCLead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
Tom Megerian, MD, PhDStudy DirectorCMO and Senior VP of Clinical Development

Media Library

L1-79 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05067582 — Phase 2
Autism Research Study Groups: Placebo Capsules, L1-79 200 mg or 300 mg Capsules
Autism Clinical Trial 2023: L1-79 Highlights & Side Effects. Trial Name: NCT05067582 — Phase 2
L1-79 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05067582 — Phase 2
Autism Patient Testimony for trial: Trial Name: NCT05067582 — Phase 2

Frequently Asked Questions

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

At what locations are participants involved in this experiment?

"Currently, this medical trial is running in 5 different sites across Columbia, Orange and Chicago; plus another 5 additional places. As such, it's important to select the closest clinic available for you to minimize your travel demands if accepted into the study."

Answered by AI

How many participants have joined this experiment?

"Yamo Pharmaceuticals LLC, the benefactor of this trial, will be administering it from two locations: Thompson Center for Autism and Neurodevelopmental Disorders in Columbia, Missouri; and Thompson Autism Center CHOC in Orange, California. For successful execution of the experiment to take place as planned, 50 participants that meet all inclusion criteria needs to be recruited."

Answered by AI

Has the FDA authorized L1-79 for therapeutic use?

"The safety of L1-79 has been evaluated by our team at Power and rated as a 2, due to the presence of data confirming its security but no evidence verifying efficacy from Phase 2 clinical trials."

Answered by AI

Are there still openings available to partake in this medical experiment?

"Clinicaltrials.gov reveals that this clinical trial is currently recruiting participants, with the study first posted on January 25th 2022 and last updated on March 7th 2022."

Answered by AI

Does the trial encompass elderly individuals aged 80 or over?

"This clinical trial is recruiting young participants aged between 12 and 21. In total, there are 234 studies for minors and 47 for those over 65 years old."

Answered by AI

Might I fulfill the prerequisites to join this research project?

"Candidates for this trial must be between 12 and 21 years old, diagnosed with early infantile autism. A total of 50 participants are being recruited."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
< 18
What site did they apply to?
Thompson Autism Center CHOC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

As an autistic woman, I am curious about modern research. Hoping to find new and alternative ways to thrive with asd and live a full life.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder
2022. "A 12-Week Crossover Study to Assess the Efficacy, Safety and Tolerability of L1-79 in Subjects Aged 12-21 Years With Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05067582.
All > Autism San Diego > Autism
~2 spots leftby Jun 2024
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