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Study of Intranasal Ketamine for Social Impairment in Autism Spectrum Disorder

NCT02611921 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-10-12

No results posted yet for this study

Summary

The purpose of the study is to determine if intranasal ketamine shows initial evidence of safety, tolerability and efficacy for the treatment of social impairment in individuals with Autism Spectrum Disorder.

Conditions

Interventions

DRUG

Ketamine

Ketamine will be compounded into a mucosal atomization device and self-administered or administered with assistance of a caregiver/study coordinator

DRUG

Placebo

Placebo will delivered as an atomized saline spray which will be self-administered or administered with assistance of a caregiver/study coordinator

Sponsors & Collaborators

  • Roivant Sciences, Inc.

    collaborator INDUSTRY

  • Cures Within Reach

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Logan K Wink, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-22
Primary Completion
2018-05-07
Completion
2018-05-07

Countries

  • United States

Study Locations

More Related Trials

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 NCT02611921 on ClinicalTrials.gov