Status:
WITHDRAWN
A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder
Lead Sponsor:
TO Pharmaceuticals
Conditions:
Autistic Disorder
Eligibility:
All Genders
2-8 years
Phase:
PHASE2
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...
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 al...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05413187
Start Date
September 1 2020
End Date
September 1 2022
Last Update
June 9 2022
Active Locations (1)
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1
Soroka University Medical Center
Beersheba, Israel, 8410101