Clinical Trials

An Open Label Observational Study of Safety and Efficacy of a Pharmaceutical grade Cannabis Medicine (MediCabilis™-CBD extract Oil) in Patients undergoing Medicinal Cannabis Therapy for Different Indications

Type of Study/Intervention

Observational

Recruitment Status

Recruiting

Form of MS

People with any form of MS or symptoms related to MS that Bod medicinal cannabis treatment is approved for (through the TGA’s special access scheme) are eligible for participation.

Brief Summary

This study is a nation-wide observational study aiming to assess the safety, tolerability and efficacy of a non-intoxicating cannabidiol-dominant medicinal cannabis in managing chronic conditions that haven’t responded well to traditional treatment options, including multiple sclerosis.
Patients who are prescribed Bod medicinal cannabis and meet the eligibility criteria will be able to participate in this important observational study.
Participation in the study involves periodically completing online questionnaires on health outcomes and response to the medication using the study app or website for the duration of the study (up to 12 months). Patients who participate will receive their first two bottles of medicine that are prescribed as complementary, and the medicines prescribed for the remainder of the study (up to 12 months) will be discounted. Pharmacy dispensing costs (typically no more than $30) and clinic consultation fees apply.

Inclusion Criteria

Patients (18+) who are prescribed Bod medicines for an approved indication and meet the eligibility criteria will be invited to participate in this study.
For full details of inclusion/exclusion see here.

Exclusion Criteria

Any severe cognitive, intellectual disability, medical or psychiatric condition that impairs the participant’s ability to provide informed consent. Patients who are using illicit forms of cannabis.

Anticipated Start Date

Study began in July 2020 and we expect recruitment to close 30 June 2021

Recruitment Contacts

Please contact Bod at info@bodpharmaceuticals.com or on 0429 508 190

Further Details

Full details of the trial can be found on the ANZCTR clinical trials database (ACTRN12620000741987) or at https://bodpharmaceuticals.com/clinical-research/.

Region

Nation-wide: NSW/ACT/SA/VIC/QLD/WA/TAS/NT/NZ

Ethics Approval

This study was approved by the Bellberry Ethics Committee on 13/05/2020 (ethics approval number, 2020-02-174).

Last updated

25 May 2021

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