Avecho Biotechnology has resumed recruitment for the final stage of a pivotal Phase III clinical trial examining a cannabidiol (CBD) capsule as a potential treatment for insomnia, following an interim review that supported continuing the study.
The randomized, double-blind, placebo-controlled trial is designed to have 519 participants complete the study. Participants receive either 75 milligrams of CBD, 150 milligrams of CBD or a placebo nightly for eight weeks, with researchers using questionnaires and daily sleep diaries to measure changes in insomnia severity and sleep quality.
An independent Data Monitoring Board reviewed unblinded data from 244 participants and unanimously recommended that the trial continue at its originally planned size. The board determined that predetermined criteria established in the trial protocol had been satisfied, while no serious adverse events were identified among the participants assessed.
Avecho remains blinded to the treatment assignments and efficacy data, meaning the final effectiveness of the CBD capsule will not be known until the trial is completed and the results are analyzed. The interim findings therefore do not establish that CBD is effective for insomnia, although the company says the decision to continue without increasing enrollment indicates the study is tracking in line with its original design.
Approximately 320 additional participants are expected to be enrolled during the second and final recruitment stage. That figure includes additional participants to account for people who may withdraw, with the goal of having 519 complete the study. Existing clinical sites in Australia have resumed recruitment, and additional locations are expected to open to accelerate enrollment. Avecho expects recruitment of the remaining participants to take approximately 12 months once those additional sites are operating.
The capsule uses Avecho’s proprietary TPM drug-delivery technology, which is intended to improve CBD absorption. The Phase III study represents the final clinical stage needed to support a potential application to Australia’s Therapeutic Goods Administration for pharmaceutical registration of the product for insomnia.
Avecho CEO Dr. Paul Gavin called the interim analysis the program’s most significant milestone, saying the company is now moving forward with recruitment of the final cohort while applying lessons from the first stage to complete enrollment more efficiently.
Those interested in taking part in the study can reach out to Avecho by clicking here.
