NTI164 in Autism Spectrum Disorder
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-25
SponsorFenix Innovation Group
About this trial
This is a double-blind, randomised, placebo-controlled study investigating the efficacy of a full-spectrum medicinal cannabis plant extract on core and associated ASD symptoms over placebo. Participants will be randomly allocated to either NTI164 or placebo at a 1:1 ratio and blood samples will be collected and surveys completed at baseline and Week 16. This study will expand efficacy and safety data of NTI164 and provide additional mechanism of action data of NTI164 in this patient cohort.
Eligibility criteria
Qualifiers
Participant is aged 6 years to 25 years (inclusive).
Participant is at a healthy weight at the discretion of the Principal Investigator.
Written informed consent from parent or legal guardian according to the local law.
Participants can comply with trial requirements.
Disqualifiers
Current diagnosis of bipolar disorder, psychosis, schizophrenia, schizoaffective disorder, or active major depression.
Has a diagnosis other than ASD that dominates the clinical presentation (e.g., ADHD).
Has a degenerative condition.
Changes in anticonvulsive therapy within the last 12 weeks.
Trial design
Treatments tested in this trial
- NTI164
- Placebo
Treatment groups
98 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fenix Innovation Group
Lead sponsor
Neurotech International Limited
Collaborator
Source ClinicalTrials.gov