Autistic Disorder Clinical Trial
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
Verified date | June 2022 |
Source | TO Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 8 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Israel | Soroka University Medical Center | Beer Sheva |
Lead Sponsor | Collaborator |
---|---|
TO Pharmaceuticals |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in symptoms of Autism spectrum disorder | 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. | 32 weeks | |
Secondary | change in score of The Clinical Global Impressions-Improvement (CGI-I) | 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. | 32 weeks | |
Secondary | change in score of Sensory Profile II (SP-2) | 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. | 32 weeks | |
Secondary | Changes in eye movements | 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. | 32 weeks | |
Secondary | Changes in the sleep architecture (optional) | 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). |
32 weeks |
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