Trial Profile

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of CBD TPM Capsules in Adults for Use in the Reduction of Insomnia Severity

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 02 Jul 2026

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At a glance

29 Jun 2026 According to an Avecho Biotechnology media release, company plans to engage with the US FDA and other international regulatory agencies to determine appropriate regulatory pathways for the product across specific geographic markets.
29 Jun 2026 According to an Avecho Biotechnology media release, the independent Data Monitoring Board (DMB) completed review of the unblinded interim analysis data from the pivotal Phase III clinical trial and recommend to continue to the full planned enrolment of 519 participants.
29 Jun 2026 Interim results (n=244) presented in the Avecho Biotechnology media release.

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