Observational Study of the Safety, Tolerability and Efficacy of cannabis-based medicine

Not Applicable

• Conditions: Inflammatory and Immune System - Rheumatoid arthritis; Chronic Pain; Cancer - Any cancer; Injuries and Accidents - Other injuries and accidents; Musculoskeletal - Other muscular and skeletal disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Public Health - Other public health

• Registration Number: ACTRN12622001133729
• Lead Sponsor: Medlab Clinical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-17
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Patients who have been prescribed MC-1019 and/or MC-1022 for a condition that is not multiple-sclerosis-related spasticity, or seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
2. Prospective participants greater than or equal to 18 years of age at time of entry on study
3. Prospective participants have the cognitive ability to understand the informed consent process and to give informed consent to participate in the observational study;
4. Prospective participants are eligible to be lawfully prescribed MC-1019 and/or MC-1022 by the Participating Doctor;
5. Prospective participants are able to visit their Participating Doctor’s clinic as required while being treated with MC-1019 and/or MC-1022 and are able to provide information as required for the duration of the study;
6. Prospective participants agree to abstain from using cannabis products other than MC-1019, and/or MC-1022 for the duration of their participation in the study.

Exclusion Criteria

1. Prospective participants will be ineligible if they have been prescribed MC-1019 and/or MC-1022 for a condition that is multiple-sclerosis related spasticity, or seizures associated with Lennox-Gastaut syndrome and Dravet syndrome2.
2. Prospective participants will be ineligible if they have a hypersensitivity to cannabinoids or to any of the study treatment excipients;
3. Pregnant, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months), or women who are planning on becoming pregnant. Estrogen-based oral contraceptives are not considered reliable forms of contraception during this study due to drug interaction with CBD;
4. Prospective participants judged by the Principal Investigator to be ineligible for participation as study participants for any reason;
5. Prospective participants will be ineligible if they are unwilling or unable to perform study procedures as described in the study protocol.
6. Prospective participants will be ineligible if they have concurrent recreational or medicinal cannabinoid use (other than the study treatments).
7. History of substance abuse

Study & Design

• Study Type: Observational
• Study Design: Not specified