| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03202303 | Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD) | PHASE2 | RECRUITING | 100 | — | — | Apr 12, 2019 | Feb 1, 2027 | Oct 22, 2025 | 2 | United States |
Change in aberrant behavior from baseline will be assessed using the irritability subscale of the ABC. The ABC is an informative rating instrument that was empirically derived by principal component analysis to measure behavior in those with developmental disability and autism spectrum disorder (ASD). The ABC-I will be completed by any adult who knows the patient well, such as a parent/caregiver. The ABC-I subscale consists of 15 items that address the presence of aggression, tantrums, and/or self-injury. Scores for each item on the subscale range from 0 (no problem at all) to 3 (problem is severe in degree), yielding an overall possible score for the subscale from 0-45, such that higher scores are indicative of increased severity of irritability. Scores will be summarized by study arm using basic descriptive statistics.
| Arm | Type | Description |
|---|---|---|
| Cannabidivarin (CBDV) | EXPERIMENTAL | Weight-based dosing of 10 mg/kg/day of CBDV for 12 weeks |
| Matched Placebo | PLACEBO_COMPARATOR | Weight-based dosing of 10 mg/kg/day of placebo for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Cannabidivarin | DRUG | Weight-based dosing of 10 mg/kg/day of CBDV |
| Matched Placebo | DRUG | Weight-based dosing of 10 mg/kg/day of placebo |
Inclusion Criteria 1. Male or Female pediatric outpatients aged between and including ages 5 to 18. Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the ADOS-2 and DSM-5 criteria.\*During special circumstances (e.g. COVID-19 pandemic) where the ADOS-2 cannot be performed due to site restric...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 3 | PHASE3 | KarXT, KarX-EC |
| MapLight Therapeutics, Inc. | MPLT | 1 | PHASE2 | ML-004 / |
| Definium Therapeutics, Inc. | DFTX | 1 | PHASE2 | DT402 ) |
| Plus Therapeutics, Inc. | PSTV | 1 | NA | Undisclosed |
| SciSparc Ltd. | SPRC | 1 | NA | SCI-210, CBD oil |
| Journey Medical Corp. | DERM | 1 | — | Undisclosed |