Dose-response characterization of VER-01 in the treatment of patients with chronic non-specific low back pai

Phase 1

Recruiting

• Conditions: For the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.; MedDRA version: 21.0Level: LLTClassification code: 10024891Term: Low back pain Class: 10028395; MedDRA version: 20.0Level: PTClassification code: 10003988Term: Back pain Class: 100000004859; MedDRA version: 20.0Level: SOCClassification code: 10028395Term: Musculoskeletal and connective tissue disorders Class: 17; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2023-507358-34-00
• Lead Sponsor: Vertanical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-15
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

Patient meets the Quebec Task Force (QTF) classification system of categories 1 to 3 of low back pain, Willingness to not take or use any prohibited medication during trial participation. The intake or use of any additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics and muscle relaxants), during trial participation is prohibited (except rescue medication). Likewise, strong inhibitors, substrates, or inducers of CYP2C9 and CYP3A4 are considered prohibited concomitant medication in this trial, Male and female patients = 18 years of age, Provision of informed consent form voluntarily signed and dated by the patient, For female patients of childbearing potential and male patients of reproductive potential: use of a reliable contraceptive method (Pearl index < 1) at least 1 month before the start of the trial and willingness to use it during trial participation and 3 months after the last intake of the test or comparative intervention, Patient understands the local language and is willing and able to comply with scheduled visits, treatment plan, eDiary, and other trial-related procedures throughout trial participation, Chronic (= 3 months) non-specific pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). Non-specific pain refers to pain without a clear specific somatic cause, for which targeted therapy can have a positive effect on the course of the disease. Such somatic causes are e.g., herniated vertebral disk, spinal canal stenosis, inflammatory back pain, osteoporosis, fracture, infection, tumor, spondylolisthesis, Patients with indicated opioid drug treatment* where previous optimized treatments** with non-opioid analgesics (including combinations) 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 realization of activating measures, or if the patient has unbearable functional disabilities as a result of the pain, despite regularly performing these measures, or if non-drug therapies are not indicated ** Treatment is considered optimized 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, Low back pain intensity on average = 4 points on an 11-point NRS in the last 4 weeks prior Visit 1 *; *Country specific additional requirement for Czech Republic: Low back pain intensity on average = 8, In case of non-drug therapy in the 4 weeks prior to Visit 1 (e.g., exercise or behavioral therapy, acupuncture, massage, thermotherapy) that significantly modulates pain perception: the non-drug therapy was unchanged and is still ongoing at Visit 1 and all requirements for continuation of the therapy throughout the trial are given (e.g., prescription, patient's compliance). Ongoing non-drug therapies should be continued unchanged during trial participation

Exclusion Criteria

Patients with a known history of alcohol/drug/medication abuse (except nicotine) or any dependency or addiction (physical or behavioral) and previous or current use of methadone, Patients deemed non-responsive to cannabis treatment due to medical history, Start of or planned start of an analgesic treatment or non-drug therapy, that significantly modulates pain perception, during trial participation, Planned surgery or other invasive procedure that requires analgetic treatment or might cause pain that could interfere with the low back pain intensity assessment, Patients with history of cancer in the last 5 years prior to Visit 1. Except for cutaneous basal cell or squamous cell cancer resolved by excision without recurrence and cervical cancer in situ resolved by excision with negative pap test, Painful comorbidities which could interfere with the low back pain intensity assessment during the trial, Known history of human immunodeficiency virus (HIV) infection, Severe forms of the following diseases: anaemia, haematological/autoimmune/endocrine/renal/hepatic/ respiratory/cardiovascular/neurological/gastrointestinal/ symptomatic peripheral vascular diseases, Cardiovascular event within the last 3 months prior to Visit 1, Poorly managed high blood pressure and/or untreated hypothyroidism, Patients with bilirubin metabolic disorder (e.g., Crigler-Najjar syndrome, Rotor syndrome), Evidence of drug abuse or illegal drugs by urine drug test performed at Visit 1, Known history of major trauma or back surgery within the last 6 months prior to Visit 1, Known history of previous or current severe psychiatric illness, Known history of previous or current severe depression (not due to chronic low back pain) (assessed by Patient Health Questionnaire – 9) and/or suicidal ideation (assessed by Columbia-Suicide Severity Rating Scale) at Visit 1, Known history of previous or current epilepsy or seizure disorder, Known intolerance or hypersensitivity to ingredients of rescue medication, VER-01, and/or placebo (e.g., sesame oil), Participation in another clinical interventional trial within the last 30 days prior to Visit 1 or previous participation in a trial for VER-01, Occupational groups with primary activity of operating machinery and driving motor vehicles, Planned blood donation, planned pregnancy, or planned donation or freezing of sperm or oocytes during trial participation and 3 months after end of trial participation, Pregnant or breastfeeding female patients, Patient is unable to provide written informed consent, in need for care, has a guardian/caretaker, is immobile, or is particularly vulnerable (e.g., imprisoned; institutionalized by an administrative or judicial authority; dependent or employed by the Sponsor, an external service provider of the Sponsor (involved in the conduct of the trial), the investigator, or the trial site), Known use of THC-containing drugs within 30 days prior to Visit 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to characterize the dose-response relationship of VER-01 in terms of pain reduction in patients with chronic non-specific low back pain when drug treatment is indicated and a previous optimized treatment with non-opioids has not led to sufficient pain relief or was unsuitable due to contraindications or intolerance.;Secondary Objective: The secondary objective is to evaluate the efficacy using additional outcome measures, the safety (including the potential for dependency and abuse) and the tolerability of VER-01 compared to placebo.;Primary end point(s): The primary endpoint is the change in mean pain intensity measured on a 11-point numerical rating scale (NRS) from Baseline (Week -1) to the end of the Treatment Phase (Week 7 of the Treatment Phase).