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A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05413187
Recruitment Status : Withdrawn (withdrawn due to COVID-19)
First Posted : June 9, 2022
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
TO Pharmaceuticals

Brief Summary:
This single center, double-blinded, randomized, placebo-controlled crossover trial will assess the efficacy and safety of extraction of cannabis flowers dissolved in olive oil (30% CBD and 1.5% Δ9-THC) vs. placebo in patients diagnosed with Autism Spectrum Disorder. The trial will contain two phases in which patients will first receive a twelve-week treatment of either cannabis or placebo followed by four weeks wash out period and another twelve weeks of crossover in the trial arms.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Medical Grade Cannabis oil Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Approximately forty children between the ages of two to eight years old with a documented diagnosis of Autism.

The trial population will be randomized in a 1:1 ratio.

Masking: Double (Participant, Investigator)
Masking Description: During the trial procedures, SCRC coordinators and the sponsors will be exposed to the trial randomization. All other personnel including principle investigator, investigators, research assistants etc. will be blinded to the randomization and trial arms.
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo Controlled, Randomized Trial to Assess the Efficacy and Safety of Medical Grade Cannabis (MGC) in Children Diagnosed With Autism Spectrum Disorder
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Medical Grade Cannabis oil 30% CBD ,1.5% Δ9-THC
during phase 1; subjects will receive cannabis oil. They will receive treatment for twelve weeks, following a four-week washout period without any treatment. In the second phase, a crossover of trial arms will take place and patients who received cannabis oil will then receive placebo and vice versa. Clinical evaluation will take place after completing each phase.
Drug: Medical Grade Cannabis oil
MGC, 30% CBD and 1.5% Δ9-THC
Other Name: Cannabis oil

Placebo Comparator: Olive oil and Chlorophyl
during phase 1; subjects will receive placebo. They will receive treatment for twelve weeks, following a four-week washout period without any treatment. In the second phase, a crossover of trial arms will take place and patients who received cannabis oil will then receive placebo and vice versa. Clinical evaluation will take place after completing each phase.
Drug: Placebos
Olive oil and Chlorophyl




Primary Outcome Measures :
  1. change in symptoms of Autism spectrum disorder [ Time Frame: 32 weeks ]
    Superiority in reducing symptoms of Autism spectrum disorder as described and quantified via parent questionnaires and clinical assessment held by a specialized physician, in five main categories - sensory behavior, social relating, body and object use, language and communication skills, and social and adaptive skills. Clinical estimation will be held via the Aberrant Behavior Checklist-Community (ABC-C) questionnaire. Clinical estimation will be performed at the beginning and the end of each phase. Comparison will be held between clinical estimation results after treatment with MCG versus after treatment with placebo for both arms.


Secondary Outcome Measures :
  1. change in score of The Clinical Global Impressions-Improvement (CGI-I) [ Time Frame: 32 weeks ]
    Superiority in reducing symptoms of Autism spectrum disorder as described and quantified via parent questionnaire - The Clinical Global Impressions-Improvement (CGI-I). Clinical estimation will be performed at the beginning and the end of each phase. Comparison will be held between clinical estimation results after treatment with MCG versus after treatment with placebo for both arms.

  2. change in score of Sensory Profile II (SP-2) [ Time Frame: 32 weeks ]
    assessed by the Sensory Profile II (SP-2) questionnaire. Parents will answer the questionnaire at the beginning and the end of each trial phase and a comparison will be held within each arm according to baseline and between both arms.

  3. Changes in eye movements [ Time Frame: 32 weeks ]
    tracking as participants observe movies with social information. An eye tracking (ET) experiment will be performed at the beginning and end of each phase to examine changes in the way the children observe movies with social information (e.g. children playing). A comparison will be held within each arm according to baseline and between both arms.

  4. Changes in the sleep architecture (optional) [ Time Frame: 32 weeks ]

    Parents will receive an explanation regarding the option to participate in an overnight EEG exams performed in the sleep laboratory at SUMC. This test is not mandatory for participation in the trial but will help researches assess the influence cannabis has on brain activity during sleep. Participating children and parents will be invited to three overnight EEG exams throughout the trial: right after enrollment and before initiating the trial (baseline), again right SCRC17039 Version 1.1, March 2018 Page 34 of 51 CONFIDENTIAL This material is the property of TO Pharma LLC. The information is confidential and is to be used only in connection with matters authorized by the sponsor and no part of it is to be without prior written permission from TO Pharma LLC.

    after the end of phase one (week 12-16), and a third and final exam right after the end of phase two (week 28-32).




Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Children ages two to eight years old with a documented diagnosis of ASD.
  • Children with a previous report of behavioral issues characterized by aggression, anxiety, restlessness, sleep disturbances and/or self-harm, all as a part of the ASD, as documented in previous clinical estimation and examination.
  • Hebrew speaking and reading.

Exclusion Criteria:

  • Children that are treated with cannabis, anti-psychotic drugs or stimulants.
  • Children with a comorbidity of heart, liver, kidney or hematologic disease.
  • Children that are treated with one of the following drugs: Astemizole, Cisapride, Pimozide or Terfenadine.
  • Children that suffer from epilepsy
  • Children which themselves or a first-degree family member suffer from psychosis and/or another mental illness.
  • Children in any condition in which the investigator is of the opinion that participating in the study is not the best option for them.
  • Children who underwent surgery during the 30 days prior to the trial.
  • Children that are participating in another trial which includes any intervention.

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): NCT05413187


Locations
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Israel
Soroka University Medical Center
Beer Sheva, Israel, 8410101
Sponsors and Collaborators
TO Pharmaceuticals
Investigators
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Study Director: Lihi Bar-LEv Clinical team manager
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Responsible Party: TO Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05413187    
Other Study ID Numbers: SCRC17039
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TO Pharmaceuticals:
Cannabis
Autism
Additional relevant MeSH terms:
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Marijuana Abuse
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders