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Study of Intranasal Ketamine for Social Impairment in Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT02611921
Recruitment Status : Completed
First Posted : November 23, 2015
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Roivant Sciences, Inc.
Cures Within Reach
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE November 17, 2015
First Posted Date  ICMJE November 23, 2015
Last Update Posted Date October 12, 2018
Actual Study Start Date  ICMJE December 22, 2015
Actual Primary Completion Date May 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Intranasal Ketamine for Social Impairment in Autism Spectrum Disorder
Official Title  ICMJE Intranasal Ketamine Use in Autism Spectrum Disorder: A Placebo-Controlled Crossover Pilot Study
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Crossover Group: Ketamine verses Placebo

    Phase 1: Two ascending doses of intranasal ketamine

    Two week washout

    Phase 2: Two doses of placebo

    Interventions:
    • Drug: Ketamine
    • Drug: Placebo
  • Experimental: Crossover Group: Placebo verses Ketamine

    Phase 1: Two doses of placebo

    Two week washout

    Phase 2: Two ascending doses of intranasal ketamine

    Interventions:
    • Drug: Ketamine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2015)
24
Actual Study Completion Date  ICMJE May 7, 2018
Actual Primary Completion Date May 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02611921
Other Study ID Numbers  ICMJE 2015-2494
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE
  • Roivant Sciences, Inc.
  • Cures Within Reach
Investigators  ICMJE
Principal Investigator: Logan K Wink, MD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP