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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
Must not have
Any disease that requires treatment with immunosuppressive drugs
A diagnosis of Fragile-X syndrome or Rett syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

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
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I can take pills by myself or have someone who can help me.
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I live with my parent or primary caregiver.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on medication that weakens my immune system.
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I have been diagnosed with Fragile-X syndrome or Rett syndrome.
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I do not have any major health issues that would interfere with the study.
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I need more than 3 medications for conditions related to my autism.
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I do not have any uncontrolled chronic conditions like seizures, heart disease, or asthma.
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I am taking medication that affects my heart's electrical cycle.
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I am taking medications not approved for autism spectrum disorder.

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

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
Common treatments for Autism Spectrum Disorder (ASD) often involve neurochemical modulation and behavioral interventions. Neurochemical modulation aims to balance neurotransmitter levels in the brain, which can help reduce symptoms like social withdrawal and repetitive behaviors. Behavioral interventions, on the other hand, focus on enhancing social skills, communication, and adaptive behaviors through structured therapy. These treatments are crucial as they can significantly improve the quality of life for individuals with ASD by addressing core symptoms and aiding in better social integration.
Measuring reinforcement learning and motivation constructs in experimental animals: relevance to the negative symptoms of schizophrenia.At the crossroads: the intersection of substance use disorders, anxiety disorders, and posttraumatic stress disorder.Dopaminergic modulation of semantic priming in healthy volunteers.

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
~17 spots leftby Jul 2025