Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism

PHASE2RecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

October 5, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

March 3, 2028

Conditions
AutismAutism Spectrum Disorder
Interventions
DRUG

Terpenes-Enriched CBD-Predominant Oil

Oral cannabidiol (CBD; 7.2 mg/kg/day), tetrahydrocannabinol (THC; 0.257 mg/kg/day, equivalent to 1:28 of the CBD dose), and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD/THC: 280/10 mg per g) produced by Bazelet Group, Israel.

DRUG

Placebo

Oral olive oil with added flavors to mimic the appearance, texture, and taste of the study drug, administered in two daily doses.

DRUG

Terpenes-Enriched CBD Oil (THC-Free)

Oral cannabidiol (CBD; 7.2 mg/kg/day) and terpenes (0.5 mg/kg/day), administered in two daily doses. The formulation is an olive oil-based solution (CBD- 280 mg per g) produced by Bazelet Group, Israel.

Trial Locations (1)

9640610

RECRUITING

Shaare Zedek Medical Center, Jerusalem

All Listed Sponsors
lead

Bazelet Nehushtan LtD.

INDUSTRY

NCT07199218 - Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism | Biotech Hunter | Biotech Hunter