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Cannabis oil

Phase 3

Autism Spectrum Disorder | Small molecule | Psychiatry |Intercure Ltd.|Trials Updated: Jul 31, 2024

Cannabis oil development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jan 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

Cannabis oil clinical trials

Cannabis oil · 1 trial · 1 indication

Phase 3 1
NCT05212493The Effects of Medical Cannabis in Children With Autistic Spectrum DisorderAutism Spectrum Disorder
COMPLETED128 Analytics
PHASE3COMPLETED
The Effects of Medical Cannabis in Children With Autistic Spectrum Disorder
Autism Spectrum DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Cannabinoids levels change
3 months

To compare CBD, THC their and metabolites blood levels before and after intervention

Changes in attention span
6 months

To characterize the effect of medical cannabis treatment on the attention span using Conners teacher questionnaires. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

Changes in cognitive level
6 months

To examine the effect of cannabis treatment on cognitive level using part of Wechsler test. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

Comparison of efficacy between two different cannabis oil products
6 months

To compare efficacy of medical cannabis products with the same CBD: THC ratio in terms of communication skills using ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

Changes in adaptive behavior
6 months

To examine the effect of cannabis treatment on adaptive behavior as per ADOS test. Significant change is defined as a change of 10% in raw questionnaire score between baseline and 6 months.

Changes in violent behavior
6 months

To examine the effect of cannabis treatment on violent behavior as per specific trial-designed questionnaire. Significant change is defined as a change of 10% in questionnaire score between baseline and 6 months.

Secondary Endpoints

Side effects
6 months
Therapeutic failure
6 months
Changes in sleep problems
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Seach CBD:THC 20:1 cannabis oilACTIVE_COMPARATORcannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Seach LTD and oil manufactured by Nextar Pharma LTD.
Candoc CBD:THC 20:1 cannabis oilACTIVE_COMPARATORcannabis oil containing CBD:THC ratio of 20:1. plant material is grown by Candoc LTD and oil manufactured by Panaxia LTD.

Interventions

NameTypeDescription
Cannabis oilDRUGCannabis oil 20:1 CBD:THC ratio
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Eligibility Criteria

Age Range5 Years to 25 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 sym...

Countries:Israel
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Competitive Landscape -Autism Spectrum Disorder 23 trials

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