NCT05067582

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

A Randomized, Double-Blind, Chronic Dosing (12-weeks), Two-Period, Placebo-Controlled, Crossover, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Two Doses of L1-79 for the Treatment of the Core Deficits in Social-Communication Interaction in Adolescents and Young Adults With Autism Spectrum Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Yamo Pharmaceuticals LLC · Industry
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy, safety and tolerability of L1-79 in participants aged 12-21 years who have been diagnosed with ASD with a score of \>/= 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II), and a score of \>/= 4 on the Clinical Global Impression of Severity of Illness (CGI-S) weighted for socialization.

Conditions

• Autism Spectrum Disorder
• Autism

Interventions

Type	Name	Description
DRUG	L1-79	tyrosine hydroxylase inhibitor

Timeline

• Start date: 2022-01-25
• Primary completion: 2024-06-18
• Completion: 2024-06-21
• First posted: 2021-10-05
• Last updated: 2024-07-31

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study