EUCTR2020-000107-36-AT进行中（未招募）1 期
Proof of efficacy, maintenance of efficacy, long-term safety and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in a multicenter study in the treatment of patients with chronic non-specific low back pain
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 808
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female patients (18 years and older)
- •2. Chronic (for at least three months) non-specific pain in the lower back (between the lower ribcage and the gluteal folds)
- •3. Pain intensity on average at least 4 points on an 11-point NRS (one month before the start of the study)
- •4. Patients with indicated drug treatment* where previous optimised treatments** with non-opioid analgesics have not led to sufficient pain relief or
- •were unsuitable due to contraindications or intolerance.
- •* Drug treatment is indicated if analgesic drug therapy is considered supportive for the realisation of activating measures, or if the patient has
- •unbearable functional disabilities as a result of the pain, despite regularly performing these measures.
- •** Treatment is considered optimised when
- •I. a further increased drug dose is unsuitable from a medical perspective considering side effects and/or
- •II. it is not expected that a higher drug dose would result in a further advantage in terms of efficacy.
- •5. Willingness of both men and women to use a reliable method of contraception during study participation and for three months after taking the last
- •dose of the IMP
- •6. Signed patient information and informed consent form
- •7. Understanding of the English language, ability to give consent and compliance
- •8. The patient has understood the instructions to avoid changes in lifestyle and dietary habits
- •9. The patient has understood the principle of the patient diary and gives their consent to keep it as instructed
- •Additional for Phase A
- •a1. The average value of the pain intensity in the morning of the 7 days before visit A2 (study week -1) must be at least 4 points on an 11-point NRS.
- •The last 7 entries of the pain intensity before visit A2 in the patient diary are used for the calculation (there must be at least 5 pain intensity
- •readings in the morning from the study week -1)
- •a2. Willingness not to take any analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) during participation in study
- •Phase A (except rescue medication)
- •a3. Willingness to continue a current non-drug therapy unchanged as planned during participation 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 medically safe
- •b4. Willingness not to take any additional analgesic medication (nonopioid and opioid analgesics as well as adjuvant analgesics) during the last two
- •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 medically safe
- •Additional for Phase D
- •d1. Previous and complete participation in Phase B until and including Visit B10
- •d2. Patient has experienced a morning pain score improvement of at least 30% in treatment Phase B (mean morning pain score of study Week 43
- •compared to the mean morning pain score in the 7 days prior to visit A2 (study week -1), there must be at least four values from study Week 43
- •and five values from study week -1)
- •d3. Patient wishes to participate voluntarily in the study
- •d4. From the investigator's point of v
排除标准
- •1. Professional groups for which the ability to operate machinery and drive vehicles is the primary activity (including truck, bus and forklift drivers,
- •2. Alcohol/drug/medication abuse and previous or current intake of methadone in the patient's medical history or suspected by the investigator
- •3. Intake of analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) within seven days prior to the start of the study
- •4. Taking cannabis-based medicinal 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, symptomatic peripheral 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) currently or in the past, severe depression not due to chronic low back pain
- •currently or in the past, or individuals at risk of suicide (examined using the MINI questionnaire: when at least one module is fulfilled)
- •9. Severe mental illness (psychosis, schizophrenia, bipolar disorder, severe depression, anxiety disorder) currently or in the past in a firstdegree relative
- •(parents and children); suicide in a first-degree relative (parents and children)
- •10. Patients with an active cancer or tumor-related pain or severe pain due to physical injury
- •11. Other painful comorbidities, excluding low back pain, that could interfere with the patient's evaluation during the study or the assessment of pain
- •12. Well-known strong adverse events in connection with cannabis consumption before the start 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 or sperm
- •16. Pregnancy, breastfeeding, desire to have children (within the next 20 months)
- •17. Participation in another clinical interventional trial within the past 30 days before the start of the study
- •18. Inability to give consent, care dependency, patient has a legal guardian/caregiver, or is immobile
- •19. The patient is in need of special protection (e.g., incarcerated; institutionalized by a court or judicial authority; in a dependent or
- •employment relationship with the sponsor, an external service provider of the sponsor (who is involved in the study conduct), 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 in Phase A.
- •Additional for Phase D
- •d1. Intake of additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) within 21 days prior to the start of study
- •Phase D (except rescue medication).
- •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, it was not maintaine
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