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
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- change in symptoms of Autism spectrum disorder
Study Overview
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.
Detailed Description
Visit 1 - Screening and Enrollment The screening and enrollment procedures will take place at the Preschool Psychiatric Unit in Soroka University Medical Center (SUMC). Parents of children who meet all inclusion criteria and none of the exclusion criteria will be offered to participate in this trial. Interested parents will sign an informed consent form (ICF) and receive a copy. A medical cannabis license request will be sent to the Medical Cannabis Unit ("Yakar") for cannabis treatment for the child and upon approval the patient will be enrolled to the trial.
Medical history will be assessed, patients who do not have a general and neurologic exam during the past year previous to the initiation of the trial will be referred to their physician. Clinical and behavioral assessment will be performed by the investigator, vital signs and weight and height will be measured, and a urine sample will be taken. All concomitant medication taken by the patient will be documented.
The YAKAR's medical cannabis license application form and a confidentiality waiver form will be sent to the YAKAR. The physician will explain to the patient the medical license conditions and that the patient's participation in the trial can be terminated at any time.
Visit 2 - Randomization and Initiation of Phase 1 When the medical cannabis license arrives, a copy of the patient's license will be included into the trial source documents. Prior to randomization inclusion and exclusion criteria will be re-assessed to make sure the patient is eligible to participate in the trial.
A clinical and behavioral evaluation will be held by the investigator and will also include the following questionnaires:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 2 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Medical Grade Cannabis oil (Drug)
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.
Intervention: Placebos (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- change in score of The Clinical Global Impressions-Improvement (CGI-I)(32 weeks)
- change in score of Sensory Profile II (SP-2)(32 weeks)
- Changes in the sleep architecture (optional)(32 weeks)
- Changes in eye movements(32 weeks)