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Harmony Trial: What the NTI164 Autism Study Actually Reported

By Benjamin Caplan, MD

4 Min Read

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CED Clinical Relevance
#67
Notable Clinical Interest
Emerging findings or policy developments worth monitoring closely.

Mental HealthPediatricsNeurologyResearchCBDTHCSafety

Why This Matters
This randomized clinical trial matters for clinicians and their patients as it provides evidence on the effectiveness of low-THC full-spectrum cannabis extract in managing symptoms of moderate-to-severe autism spectrum disorder (ASD) in children aged 8 to 17. The findings could potentially expand treatment options for this patient population, contributing to improved clinical practice and patient care.

Clinical Summary

In the Harmony trial, 61 children and adolescents aged 8 to 17 with Level II or III autism spectrum disorder were randomized to NTI164, a full-spectrum extract containing less than 0.3% THC, or placebo for 8 weeks, and 54 were analyzed. The prespecified primary endpoint was clinician-rated overall severity on the CGI-S, which improved relative to placebo. On the caregiver-rated Social Responsiveness Scale, the total T-score did not reach statistical significance (least squares mean difference -2.71, p = 0.055); two of its five subscales separated. The largest effects in the trial were on anxiety and mood, which are associated rather than core symptoms. The trial applied no adjustment for multiplicity to secondary outcomes.

Dr. Caplan’s Take
This is a small industry-funded trial with one positive primary endpoint, and it deserves to be read at that size. The paper is titled as improving core symptoms, but its own results section reports the social responsiveness total as not statistically significant. The effects that reached significance most clearly were on anxiety and mood. That is a meaningful finding for families, and it is a different claim from changing the core features of autism. Replication by an independent group, with a multiplicity-adjusted analysis, is the next thing to wait for.

Clinical Perspective

🔬 A randomized placebo-controlled trial in children and adolescents with moderate-to-severe autism spectrum disorder reported improvement on its primary measure of overall clinical severity, with the clearest secondary effects on anxiety and mood rather than on core social communication measures. However, it’s crucial to acknowledge the complexity of this finding, as confounders such as individual response variability, concurrent medication use, and long-term effects remain to be fully explored. In clinical practice, healthcare providers may consider discussing the potential benefits and risks associated with cannabis therapy in managing symptoms of ASD, while emphasizing the need for ongoing monitoring and adjustment of treatment plans based on individual patient responses.

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📰 Primary source: Keating BA, Ogru Y, Isikgel E, Sharma K, El-Sukkari D, Fahey MC. NTI164, a novel medicinal cannabis extract, improves core symptoms of autism spectrum disorder: results from a double-blind, randomised, controlled trial (The Harmony study). Neurotherapeutics. 2026;23(5):e01033. PMID 42561512. doi:10.1016/j.neurot.2026.e01033
Funding and author affiliation: the trial was funded by Fenix Innovation Group and Neurotech International; the first three authors are affiliated with Fenix Innovation Group.

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Harmony Trial: What the NTI164 Autism Study Actually Reported

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