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Safety of L1-79 in Adolescent and Adult Males With Autism

NCT02947048 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-08-21

Study results available
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Summary

This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively randomized, placebo controlled patients and 5 open label patients at either 100 tid (three times daily) or 200 tid dosing for 28 days. The open label patients will be assessed for the purpose of understanding PK/PD and to determine if there are any EKG changes associated with the administration of L1-79. Additional safety information will be provided by the 30 patients randomized 2:1 active:placebo.

Conditions

Interventions

DRUG

L1-79

DRUG

Placebo

Sponsors & Collaborators

  • Yamo Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • John Rothman, PhD · Yamo Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-12-31
Completion
2018-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02947048 on ClinicalTrials.gov