drugset / Trial / NCT05626959
Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder
Phase 2/3
Unknown
54 enrolled
Fenix Innovation Group
Monash Health · collabNeurotech International Limited · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This is an 18 to 54 week study assessing the efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on the severity of autism spectrum disorder in young people.
Timeline
- Start
- 2022-11-30
- Primary completion
- 2023-03-01
- Completion
- 2023-11-30
Outcome
Met primary endpoint
release “NTIASD2 Phase II/III clinical trial met the primary endpoint of a statistically significant improvement in severity of illness (CGI-S) at 8 weeks between NTI164 and placebo (p<0.001)” investi.com.au ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NTI164 | Traditional medicine (herbal / TCM) | 20 mg/kg | — |