Status:
COMPLETED
The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
Lead Sponsor:
Assaf-Harofeh Medical Center
Collaborating Sponsors:
Seach Sarid Ltd
Canndoc Ltd
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
5-25 years
Phase:
PHASE3
Brief Summary
Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Data on the effects of cannabidiol rich cannabis extract use for ASD is p...
Detailed Description
Participants will be screened by the PI, a specialist neurologist. For those passing screening, license for Cannabis will be obtained at MOH. Participants will pass tests such as ADOS (communication ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- diagnosed with ASD by DSM
- IQ below 70. The investigator can include patients with IQ above 70 if they have significant ASD or comorbid symptoms.
- With significant behavior problems in for at least 6 months before recruitment
- Exclusion Criteria:
- Epilepsy with clinical symptoms
- Current or previous treatment with cannabis
- Genetic disorder that can cause ASD symptoms
- Metabolic disorder
- immunologic disorder
- liver cancer
- Participants who, in the researcher's opinion, will not cooperate in the various research procedures
- Women which are pregnant or breastfeeding.
- Psychosis or schizophrenia or past or present schizoaffective disorder, in first-degree relatives
- History of substance abuse or abuse (including cannabis use disorder or alcohol addiction) in first-degree relatives
- Hypersensitivity to coconut oil / palm oil
Exclusion
Key Trial Info
Start Date :
November 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05212493
Start Date
November 14 2019
End Date
December 31 2023
Last Update
July 31 2024
Active Locations (1)
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1
Assaf Harofeh Medical Center
Ẕerifin, Israel, 70300