✓ Translated by DotMD AI Clinical Council Source: Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #42561512 ↗

Phase III Randomized Trial: NTI164, a novel medicinal cannabis extract, improves core symptoms of autism spectrum disorder: Results from a double-blind, randomised, controlled trial (The Harmony study)

Original Paper Title: “NTI164, a novel medicinal cannabis extract, improves core symptoms of autism spectrum disorder: Results from a double-blind, randomised, controlled trial (The Harmony study)”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • NTI164 significantly improved core and associated symptoms of ASD compared to placebo. Consistent benefits reported by both clinicians and caregivers in both open label and double-blind contexts supports further clinical development of NTI164 in ASD.
  • Study Design & Sample: Phase III Randomized Trial published in Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics (2026), this phase iii randomized trial evaluating human clinical outcomes investigated: Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental disorder, characterised by difficulties with communication, social interaction, repetitive behaviours, restricted interests, and varying levels of intellectual disability. Key clinical takeaway: NTI164 significantly improved core and associated symptoms of ASD compared to placebo. Consistent benefits reported by both clinicians and caregivers in both open label and double-blind contexts supports further...

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2026-09-15; Phase III Randomized Trial; Rigor 88/100): NTI164 significantly improved core and associated symptoms of ASD compared to placebo. Consistent benefits reported by both clinicians and caregivers in both open label and double-blind contexts supports further clinical development of NTI164 in ASD.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Condition: autism-spectrum-disorder → Condition: cannabis →
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