Global Registry for the Use of Spectrum Therapeutics Cannabis Products in Subjects With Chronic Pain

Summary

Participation Requirements

Description

The present study is a prospective, observational registry designed to generate real-world data on the physician-recommended use of ST products for the management of chronic non-cancer pain in countries where these products are commercially available. The study will enroll 1500 subjects from 50-150 ...

The present study is a prospective, observational registry designed to generate real-world data on the physician-recommended use of ST products for the management of chronic non-cancer pain in countries where these products are commercially available. The study will enroll 1500 subjects from 50-150 sites in geographic regions of ST product distribution, over a 2-year period. Subjects at each site will be followed for one year to collect data on demographics, chronic pain classification, cannabis experience, treatment goals, concomitant medication(s), ST treatment regimen, clinical assessment, subject-reported outcomes, and safety. The study includes five physician-verified visits (baseline, 2, 4, 8, and 12 months), and four at-home subject-verified follow-ups (months 1, 3, 6, 10). Physician verified follow-ups can be conducted in person or via telemedicine. Additionally, should there be a need, according to the physician's judgement, there may be other unscheduled visits, either in-clinic, or via telemedicine. All data will be collected using REDCap Cloud data management platform, via online electronic case report forms (eCRFs), and questionnaires. During physician-verified visits, online questionnaires will be completed by both the physician and the subject (in the presence of a physician or study site personnel). At-home subject-verified follow-ups will be conducted via the REDCap Cloud online portal accessible by computer, tablet, or smartphone. The following activities will be completed at the Baseline Visit. The subject will receive an explanation of the study purpose and procedures, sign the electronic informed consent form (eICF), physician will review eligibility check list, if female of childbearing potential, subject will complete a urine pregnancy test. Together, physician and subject will create an account on REDCap Cloud. Together, physician and subject will complete the baseline assessment measuring: Demographics; Chronic pain classification; Cannabis experience; Concomitant medications; Treatment goal; ST treatment regimen; Brief Pain Inventory-Short Form (BPI-SF); Euro Quality of Life Assessment (EQ5D-5L). The subject will be scheduled for the first physician-verified follow-up visit approximately 2 months after the initiation of treatment with an ST product. The following activities will be completed at each physician-verified follow-up visit: Physician and subject will discuss the overall treatment regimen. Physician will review the subject's online REDCap Cloud entries. Together, physician and subject will complete the follow-up visit assessment measuring: ST treatment regimen Concomitant medications Clinician Global Impression of Improvement (CGI-I) BPI-SF EQ5D-5L Patient Global Impression of Change (PGI-C) Physician adverse events (AEs) form The following measures are to be completed by the subject for each at-home follow-up: ST treatment regimen Additional cannabis consumption BPI-SF EQ5D-5L Patient Global Impression of Change (PGI-C) Subject adverse events (AEs) log In the event of ST treatment discontinuation or study dropout, physicians will be asked to attempt to follow-up with subjects for the completion of the ST Discontinuation assessment and Exit assessment. Based on physician answers to the ST Discontinuation Assessment, subjects will either stay enrolled in the study (e.g., discontinue all cannabis treatment, but continue to be monitor by site physician for chronic pain), or be withdrawn (e.g., unwilling to stay in the study, switched cannabis licensed producer). Safety Monitoring: Spontaneous AE reporting will be entered in REDCap Cloud by the subject during subject follow-ups, using the Subject AE log. Physicians will verify and assess all AEs entered at physician follow-ups, using the Physician AEs form. All serious adverse events will be sent directly to Canopy Growth's Global Pharmacovigilance Department (GPVD) in real-time, where they will be reviewed with respect to country specific regulatory requirements. All non-serious adverse events will be sent in a monthly report to GPVD. Duration of Subject Participation and Treatment: Subjects will be followed for one year, unless the subject withdraws early, either independently or in response to physician recommendation. ST treatment will continue for as long as subjects and physicians agree that there is a benefit and treatment is tolerated. Primary endpoints Physician selection of Spectrum Therapeutics (ST) medical cannabis treatment regimen and changes over time in: average daily dose of THC and CBD (in mg); route of administration (inhaled or ingested). Secondary endpoints Subject selection of ST treatment regimen and changes over time in: average daily dose of THC and CBD (in mg); route of administration (inhaled or ingested). Change in BPI-SF responses from baseline. Change in EQ5D-5L responses from baseline. PGI-C for the target treatment goal. CGI-I for the target treatment goal. In subjects taking an opioid, changes in opioid use over time (calculated as milligram morphine equivalents [MME]/day). Among subjects taking other medication, total daily dose change over time. Safety endpoint • Incidence of AEs stratified by product and formulation. Number of Subjects (Planned): Given a continuous enrollment design, the study will include two enrollment milestones over the 2-year study period. Milestone 1, targeted for the end of year 1 will be to recruit 750 subjects. Milestone 2, targeted for the end of year 2 will be to recruit 750 subjects. To enroll a total of up to 1500 subjects. The number of subjects may vary based on the real-life use of ST products. Sites will be recruited from countries where ST products are available: Canada, Germany, and Australia. Sites from additional countries may be included as ST products are rolled out in those countries and based on site feasibility. The present study has an observational design that poses low-burden for subjects, as the number and frequency of in-clinic (telemedicine) visits represent those necessary for adequate monitoring of treatment for chronic pain and at-home follow-ups will be completed using a simple online app and take no longer than 15 minutes to complete. On this premise, no restriction was placed on the sample size based on an estimated minimum required sample. Furthermore, the observational nature of the primary endpoint (daily average dose [in mg] of THC and CBD and mode of administration [inhaled or ingested]), did not permit an a priori power analysis to estimate sample size. A sample size of 1500 subjects is consistent with similar previous observational registry studies.

Tracking Information