Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Inclusion Criteria:

1. Male and female patients (18 years and older)
2. Chronic (for at least three months) non-specific pain in the lower back (between thelower ribcage and the gluteal folds)
3. Pain intensity on average at least 4 points on an 11-point NRS (one month before thestart of the study)
4. Patients with indicated drug treatment where previous optimised treatments withnon-opioid analgesics have not led to sufficient pain relief or were unsuitable due tocontraindications or intolerance.
5. Willingness of both men and women to use a reliable method of contraception duringstudy participation and for three months after taking the last dose of the IMP
6. Signed patient information and informed consent form is available
7. Understanding of the German language, ability to give consent and compliance
8. The patient has understood the instructions to avoid changes in lifestyle and dietaryhabits
9. The patient has understood the principle of the patient diary and gives their consentto keep it as instructed Additional for Phase A a1. Pain intensity averaged at least 4 points on an 11-point NRS (there must be at least 5pain intensity readings in the morning from the run-in phase) a2. Willingness not to take any analgesic medication (non-opioid and opioid analgesics aswell as adjuvant analgesics) during participation in study Phase A (except rescuemedication) a3. Willingness to continue a current non-drug therapy unchanged as planned duringparticipation in Phase A Additional for Phase B b1. Previous and complete participation in Phase A until and including Visit A6 b2. Patient wishes to participate voluntarily in the long-term study b3. From the investigator's point of view, further participation is considered medicallysafe b4. Willingness not to take any additional analgesic medication (non-opioid and opioidanalgesics as well as adjuvant analgesics) during the last three weeks of study Phase B (except rescue medication). Additional for Phase C c1. Previous and complete participation in Phase B until and including Visit B10 c2. Patient wishes to participate voluntarily in the long-term study c3. From the investigator's point of view, further participation is considered medicallysafe Additional for Phase D d1. Previous and complete participation in Phase B until and including Visit B10 (patientsreceived Ver-01 for 26 weeks) d2. Patient has experienced a pain score improvement of at least 30% in treatment Phase B (mean value of the study week 43 compared to the mean value of the run-in phase, there mustbe at least four values from study week 43 and five values from the run-in phase) d3. Patient wishes to participate voluntarily in the study d4. From the investigator's point of view, further participation is considered medicallysafe d5. Willingness not to take any analgesic medication (non-opioid and opioid analgesics aswell as adjuvant analgesics) during participation in study Phase D (except rescuemedication) d6. Willingness to continue a current non-drug therapy unchanged as planned during study

Exclusion Criteria:

1. Professional groups for which the ability to operate machinery and drive vehicles isthe primary activity (including truck, bus and forklift drivers, pilots)
2. Alcohol/drug/medication abuse and previous or current intake of methadone in thepatient's medical history or suspected by the investigator
3. Intake of analgesic medication (non-opioid and opioid analgesics as well as adjuvantanalgesics) within seven days prior to the start of the study
4. Taking cannabis-based products within 30 days prior to the start of the study
5. HIV, dementia (which impairs the assessment of symptoms)
6. Severe forms of the following diseases: Anaemia,hematological/autoimmune/endocrinal/renal/hepatic/respiratory/cardiovascular or gastrointestinal diseases, symptomaticperipheral vascular diseases
7. Cardiovascular event in the past three months, poorly managed high blood pressure,untreated hypothyroidism, patients with Crigler-Najjar syndrome or Rotor syndrome,surgery within the past two months
8. Severe mental illnesses (e.g. psychosis, schizophrenia, bipolar disorder), severedepression that is not due to the chronic non-specific low back pain, or individualsat risk of suicide (examined using the MINI questionnaire)
9. Severe mental illness (psychosis, schizophrenia, bipolar disorder, severe depression,anxiety disorder) in a first-degree relative (parents and children); suicide in afirst-degree relative (parents and children)
10. Patients with an active cancer or tumor-related pain or severe pain due to physicalinjury
11. Other painful comorbidities, excluding low back pain, that could interfere with thepatient's evaluation during the study or the assessment of pain
12. Well-known strong adverse events in connection with cannabis consumption before thestart of the study
13. Known allergy to cannabis and/or sesame seeds and products derived from them
14. Known hypersensitivity to the ingredients of the rescue medication
15. Planned blood donation, planned sperm or egg donation, planned freezing of eggs orsperm
16. Pregnancy, breastfeeding, desire to have children (within the next 20 months)
17. Participation in another clinical trial within the past 30 days before the start ofthe study
18. Inability to give consent, care dependency, patient has a legal guardian/caregiver, oris immobile
19. The patient is in need of special protection (e.g., incarcerated; institutionalized bya court or judicial authority; in a dependent or employment relationship with thesponsor, an external service provider of the sponsor (who is involved in the studyconduct), the investigator, or the study site). Additional for Phase A: a1. In the case of a current non-drug therapy (e.g. physical or behavioural therapy,acupuncture,massage, thermotherapy), which significantly modulates the perception of pain,it was not maintained unchanged for at least eight weeks prior to study participation inPhase A. Additional for Phase D d1. Intake of additional analgesic medication (non-opioid and opioid analgesics as well asadjuvant analgesics) within 21 days prior to the start of study Phase D (except rescuemedication). d2. In the case of a current non-drug therapy (e.g. physical or behavioural therapy,acupuncture,massage, thermotherapy) that significantly modulates the perception of pain, itwas not maintained unchanged for at least nine weeks prior to the start of study Phase D.