L1-79 for Autism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called L1-79 to determine if it improves autism symptoms in teens and young adults. Participants will receive either L1-79 or a placebo (a pill that resembles the treatment but contains no active ingredients) to compare effects. The trial focuses on the treatment's effectiveness, safety, and potential side effects. Teens and young adults with autism who face noticeable social challenges and can manage daily activities with some assistance might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as antipsychotics, alpha-2 agonists, beta-blockers, and anti-hypertensives, at least 1 to 2 months before starting the study. If you're on more than 3 medications for conditions like autism, ADHD, or anxiety, you may not be eligible to participate.
Is there any evidence suggesting that L1-79 is likely to be safe for humans?
Research has shown that L1-79 has been tested for safety in people with autism spectrum disorder (ASD). In one study, 58 participants aged 12-21 took part in a 12-week trial. Neither the participants nor the researchers knew who received the actual treatment, while some participants received a placebo.
Initial results suggest that L1-79 is generally well-tolerated. Another study, which also included a placebo group, examined safety and found no severe side effects, although specific details on minor side effects were not provided.
L1-79 is still undergoing clinical trials. Researchers have gathered some safety information, but they continue to study it to ensure its safety for everyone.12345Why do researchers think this study treatment might be promising for autism?
Researchers are excited about L1-79 for autism because it offers a new approach by targeting a different biological pathway than most current treatments. While traditional options like behavioral therapy and medications such as antipsychotics primarily manage symptoms, L1-79 aims to address underlying biochemical processes. This novel mechanism could potentially improve core symptoms of autism, providing a more comprehensive treatment option.
What evidence suggests that L1-79 might be an effective treatment for autism?
Research has shown that L1-79, which participants in this trial may receive, might help treat autism spectrum disorder (ASD), particularly with core symptoms like social interaction. Previous patients experienced improvements in these areas, almost doubling the smallest change considered important, suggesting it could lead to meaningful improvements. L1-79 affects a process in the brain related to behavior. Early studies indicate it is generally safe, with only mild side effects that resolved without stopping treatment. However, more detailed studies are needed to confirm these results.34678
Who Is on the Research Team?
Tom Megerian, MD, PhD
Principal Investigator
CMO and Senior VP of Clinical Development
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive L1-79 or placebo capsules twice daily in a 12-week crossover design
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- L1-79
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yamo Pharmaceuticals LLC
Lead Sponsor