Patients (cannabis-naïve / cannabis-experienced) with a diagnosed disease for which medical cannabis is indicated in the sense of the "Cannabis as Medicine" (CAM) Act.
Conditions
Interventions
Group 1: Cannabisextract Avextra 10/10 solution or
Cannabisextract Avextra 25/0 solution or
Avextra Cannabisextract 10 % as encapsulated granulate:
2.5mg THC/ 2.5mg CBD or
Avextra Cannabisextract 1
Sponsors
Avextra Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients of any gender and ethnicity aged 18 years or older (both cannabis-naïve and cannabis-experienced). 2. Documented diagnosis of a condition for which cannabis as a medicine (CAM) is indicated (and has been and is being used according to the 2022 BfArM companion survey), e.g. for (but not limited to): - Chronic musculoskeletal pain - Neuropathic pain - Chronic tumour-related pain - Use in palliative care (e.g. inappetence, nausea, pain) - Spasticity, e.g. caused by multiple sclerosis - anorexia - Gastrointestinal diseases (e.g. Crohn's disease, ulcerative colitis) - Sleep disorders - Psychiatric diseases (e.g. ADHD, tic disorder, PTSD) - Neurological diseases (e.g. epilepsy, restless legs syndrome) - Headaches (migraine, cluster headache, tension headache) - Chronic lower abdominal pain (e.g. endometriosis) 3. Treatment with a cannabinoid justified on the basis of a justified assessment by the physician, weighing of the expected side effects and taking into account the state of the disease.
Exclusion criteria
Exclusion criteria: 1. Any other condition, disorder or observation which, in the opinion of the investigator, would interfere with the participant's ability to complete the study survey. 2. Hypersensitivity/allergy to THC or CBD or the other components of the respective dosage form. 3. Psychiatric illness related to schizophrenia/psychosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of oral cannabinoid therapy on symptom burden of the patient measured by the achievement of the personal goal with cannabis therapy AND/OR improvement of individual symptoms. Patient satisfaction questionnaire is filled in at all interview points (as well as at treatment discontinuation). Comparison between treatment groups: Baseline vs. survey time point 2 (after 1 month), survey time point 3 (after 3 months) and survey time point 4 (optional: after 6 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effect of oral cannabinoid therapy on quality of life of the patient measured by improvement in individual quality of life. WHO-5 well-being index is filled in at all survey time points (as well as at treatment discontinuation). 2. Satisfaction with the oral cannabis therapy measured by assessment of the degree of satisfaction with cannabis treatment. The patient satisfaction questionnaire is filled in at all survey time points (as well as at treatment discontinuation). Comparison between the treatment groups as described in the primary endpoint. 3. Evaluation of safety and tolerability of the oral cannabis product measured by incidence and intensity of adverse events. Documentation of adverse events at each survey time point and at treatment discontinuation with regard to incidence, type, severity and causality with adverse drug reactions (ADRs). 4. Satisfaction with the usage of the cannabis product measured by usability rating and feedback on the cannabis product. Patient satisfaction questionnaire is filled in at all survey time points (as well as at treatment discontinuation). | — |
Countries
Germany
Contacts
Public ContactAna Serrato
Avextra Pharma GmbH
Outcome results
None listed