AVE047-22 CBD in Insomnia

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

Study Population

Approximately 519 participants are planned to be randomized in to this study.

Current therapies for insomnia can involve psychological therapies including cognitive behavioural therapy, education regarding sleep, prescription and over-the-counter medications. There is currently an unmet treatment need for an effective, fast-acting, over the counter treatment for insomnia that provides natural, restorative sleep.

Avecho is developing a low dose, over-the-counter product, CBD TPM soft gel capsules for the management of symptoms associated with insomnia. The oral tablet contains cannabidiol + tocopheryl phosphate mixture (CBD TPM).

Eligible participants:

• male or female, aged 18 years and older
• have diagnosed or suspect sleep insomnia disorder
• have and can use a smart phone (for diary and questionnaires)

Subjects with an undiagnosed or unstable disease, currently using vaping products, cannabis, or sedatives, or have excessive caffeine use will not be eligible to participate in the study.

Study Visits

• A total of 8 visits over a 2‑month period, of which 4 visits are onsite and 4 visits are via telehealth
• Reimbursement for travel and any out of pocket expenses

Study Requirements

• 2 tablets taken orally once a day for 8 weeks.
• Blood and urine tests, ECG, questionnaires at selected onsite visits.
• Completion of questionnaires on electronic diary

Clinical Trials link

https://clinicaltrials.gov/study/NCT05840822