The primary objective of the study is to assess the safety and tolerability of MediCabilis.
Medicinal cannabis, CBD and hemp healthcare products company,
Bod Australia Limited (ASX: BDA) is pleased to provide additional information on its recently commenced Australia-wide, multi-clinic, open-label observational study into the effectiveness of its medicinal cannabis range, MediCabilis™ (refer ASX announcement: 16
The primary objective of the study is to assess the safety and tolerability of MediCabilis™ when used at the prescribed dose by physicians for different indications using data reported by patients during treatment. The secondary objective is to evaluate the efficacy of MediCabilis™ for different indications, including anxiety disorders, insomnia and Post Traumatic Stress Disorder (PTSD) using patient-reported outcomes.
The study will collect data from 500 patients, who will be prescribed MediCabilis™ on a regular basis over 12 months. The initiative is an open-label, observational study with no control group present and no set specified treatment method. Instead, physicians will provide treatment according to
Key inclusion criteria for the study are as follows:
- Participants can include any patient who has been prescribed MediCabilis™ through the Therapeutic Goods Administration's Special Access Scheme Category B or an authorised prescriber of medicinal cannabis;
- Participants may take MediCabilis™ in any dose, form, duration and frequency for any condition confirmed by a general practitioner or specialist, thus healthy volunteers cannot participate;
- Patients of any gender-equal or greater than 18 years may participate (no maximum age has been set);
- Prospective patients must understand the informed consent process and give informed consent to participate in the study.
Patients with any severe cognitive, intellectual disability, medical or psychiatric condition that impairs the participant's ability to provide informed consent will be excluded from the study. Further, any patients using illicit forms of cannabis will not be able to participate.
The study's principal investigators are Bod's Chief Scientific Officer Dr Adele Hosseini and Cannabis Doctors Australia's Dr Ben Jansen.
To learn more about Bod Australia, visit the company HQ here.
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