L1-79 for Autism

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yamo Pharmaceuticals LLC

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests L1-79 to see if it helps young people with Autism Spectrum Disorder (ASD) who have certain levels of intelligence and socialization issues. The goal is to find out if L1-79 can improve their symptoms.

Eligibility Criteria

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

Diagnosis of ASD based on tool that utilizes the DSM-5 criteria, confirmed with ADOS-2

I can follow the trial's requirements as per my doctor's opinion.

WASI-II standard score ≥70 at screening or within the last 12 months prior to screening

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Exclusion Criteria

I am on medication that weakens my immune system.

Presence of out-of-range hepatic or renal function tests or other unexplained abnormal laboratory value deemed clinically significant

I have been diagnosed with Fragile-X syndrome or Rett syndrome.

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Treatment Details

Interventions

L1-79 (Other)

Trial OverviewThe 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.

Participant Groups

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