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Trial record 2 of 2 for:    roivant

Study of Intranasal Ketamine for Social Impairment in Autism Spectrum Disorder

This study is currently recruiting participants.
Verified August 2017 by Children's Hospital Medical Center, Cincinnati
Sponsor:
ClinicalTrials.gov Identifier:
NCT02611921
First Posted: November 23, 2015
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Roivant Sciences, Inc.
Cures Within Reach
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
  Purpose
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.

Condition Intervention Phase
Autism Spectrum Disorder Drug: Ketamine Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Ketamine Use in Autism Spectrum Disorder: A Placebo-Controlled Crossover Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Change in Social Withdrawal subscale score of the Aberrant Behavior Checklist (ABC) [ Time Frame: Social withdrawal subscale change from baseline to final visit on day 35 ± 2 days ]
    The ABC is the gold standard parent/caregiver reported behavioral outcome measure for use in developmental disability clinical trials.


Secondary Outcome Measures:
  • Change in the Clinician-rated CGI Improvement scale (CGI-I) [ Time Frame: CGI-I change from baseline to final visit on day 35 ± 2 days ]
    The CGI-I is a 7-point scale designed to measure symptomatic change at a specific time as compared to baseline. The CGI-I will be focused on the target symptoms of social impairment. CGI-I is a gold standard measure of potential change with treatment in placebo- controlled pharmacotherapy trials in ASD


Estimated Enrollment: 24
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crossover Group: Ketamine verses Placebo

Phase 1: Two ascending doses of intranasal ketamine

Two week washout

Phase 2: Two doses of placebo

Drug: Ketamine
Ketamine will be compounded into a mucosal atomization device and self-administered or administered with assistance of a caregiver/study coordinator
Other Name: Ketalar
Drug: Placebo
Placebo will delivered as an atomized saline spray which will be self-administered or administered with assistance of a caregiver/study coordinator
Other Name: Saline
Experimental: Crossover Group: Placebo verses Ketamine

Phase 1: Two doses of placebo

Two week washout

Phase 2: Two ascending doses of intranasal ketamine

Drug: Ketamine
Ketamine will be compounded into a mucosal atomization device and self-administered or administered with assistance of a caregiver/study coordinator
Other Name: Ketalar
Drug: Placebo
Placebo will delivered as an atomized saline spray which will be self-administered or administered with assistance of a caregiver/study coordinator
Other Name: Saline

Detailed Description:
To address the significant need for effective treatment of core symptoms of Autism Spectrum Disorder (ASD), this trial is designed as a double-blind, placebo-controlled crossover pilot study of intranasal ketamine in 24 individuals with ASD ages 12- 30 years using a novel quantitative eye-tracking outcome measure to assess impact of the drug on social impairment. Additionally, to develop a ketamine-focused personalized medicine approach in ASD, the investigators will include pharmacokinetic, molecular pharmacodynamic, and electrophysiological assessments into initial systematic study.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 12 to 30 years old.
  • Weight equal to or greater than 50 kg.
  • General good health as determined by physical exam, medical history, laboratory work up, and EKG.
  • Diagnostic and Statistical Manual of Mental Disorders 5th Edition diagnosis of autism spectrum disorder (not associated with Fragile X Syndrome or other known genetic syndrome) as confirmed by the Autism Diagnostic Observation Schedule at screen or previous (within last 5 years) if available.
  • Valid Intelligence Quotient (IQ) score greater than or equal to 50 as confirmed via testing (Leiter-3) at screen or previous (within last 5 years, any valid testing acceptable).
  • Clinical Global Impressions-Severity score of 4 (Moderately Ill).
  • Score of 10 on the Social Withdrawal subscale of the Aberrant Behavior Checklist.
  • Stable dosing of all concomitant psychotropic medications for five half-lives prior to screening visit and during the study.
  • Presence of parent/guardian or significant other or caregiver willing to serve as informant for behavioral outcome measures.

Exclusion Criteria:

  • Presence of co-morbid schizophrenia, schizoaffective disorder, bipolar disorder with psychosis, bipolar disorder or psychosis not otherwise specified. Comorbid diagnoses determined by psychiatrist clinical interview and use of Diagnostic and Statistical Manual of Mental Disorders 5th Edition diagnostic criteria.
  • History of drug or alcohol abuse.
  • Presence of cardiac disease including coronary artery disease, congestive heart failure, or uncontrolled hypertension per medical history (individuals with ≥ 2 blood pressure readings of ≥140/90 during screen/baseline will be excluded).
  • Airway instability, tracheal surgery, or tracheal stenosis per medical history.
  • Central nervous system masses or hydrocephalus per medical history.
  • Porphyria, thyroid disorder, or thyroid medication use per medical history.
  • Glaucoma or other cause of increased intraocular pressure per medical history.
  • Allergy to ketamine.
  • Current use of drugs with concomitant modification of non-competitive N-methyl-D-aspartate glutamate activity (acamprosate, amantadine, memantine, d-cycloserine etc.)
  • For female subjects of child bearing potential, a positive pregnancy test.
  • Any major chronic medical or chronic respiratory illness considered to be uncontrolled by the Principal Investigator.
  • Inability to tolerate study procedures or study drug per the discretion of the Principal Investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611921


Contacts
Contact: Study Coordinator 513-636-0523 autism@cchmc.org

Locations
United States, Ohio
Cincinnati Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kaela O'Brien    513-803-7226    kaela.obrien@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Roivant Sciences, Inc.
Cures Within Reach
Investigators
Principal Investigator: Logan K Wink, MD Children's Hospital Medical Center, Cincinnati
  More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02611921     History of Changes
Other Study ID Numbers: 2015-2494
First Submitted: November 17, 2015
First Posted: November 23, 2015
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Ketamine
Social Impairment
Autism
Autistic Disorder

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action