Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
Search
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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Insomnia
  • Focus Registrational; Therapeutic Use
  • Sponsors Avecho Biotechnology

    • Most Recent Events

    • 03 Mar 2025 According to an Avecho Biotechnology media release, the company announced it has signed an exclusive ten-year development and licensing agreement with Sandoz Group AG for the commercial rights to Avecho's Phase III cannabidiol capsule for insomnia in Australia. Sandoz has agreed to an upfront licensing fee of US$3M (approx. A$4.8M[1]) for the exclusive commercial rights to the CBD product for insomnia in Australia. company will continue to fund and oversee the ongoing Phase III trial.
    • 14 Mar 2024 According to an Avecho Biotechnology media release, the company expects to commence recruitment for the Phase III trial this month, with a total of five sites to be used for the study, located in Melbourne, Sydney, Central Coast, Brisbane and Perth.
    • 14 Mar 2024 According to an Avecho Biotechnology media release, the company has recently completed a meeting with the Australian Therapeutic Goods Administration (TGA), where the Company presented its final Phase III clinical trial design and planned submission strategy.The TGA has not recommended any changes to the trial design and submission strategy and the program will commence as planned.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top