Efficacy and Safety of VER-01 in the Treatment of Patients With Radicular Chronic Low Back Pain (NCT06956014) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy and Safety of VER-01 in the Treatment of Patients With Radicular Chronic Low Back Pain
810 participantsStarted 2026-09
Plain-language summary
The aim of the trial is to prove the efficacy and safety of VER-01 corresponding to 22.5 mg or 32.5 mg THC compared to placebo in patients with chronic low back pain (CLBP) with a radicular component for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Chronic (≥ 6 months) pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). CLBP patients without a clear specific somatic cause, for which targeted therapy can have a positive effect on the course of the disease.
* Participant meets the Quebec Task Force (QTF) classification system of category 3 of low back pain
* 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
Exclusion Criteria:
* Any painful comorbidity which could, in the opinion of the investigator, interfere with the low back pain intensity assessment during the trial participation
* Pregnant or breastfeeding female patients
* Known history of previous or current severe psychiatric disorder as per DSM-5 (e.g., schizophrenia, bipolar disorder, severe anxiety disorder, psychotic disorder, post-traumatic stress disorder), or currently taking antipsychotic medication.
* Cardiovascular event or clinically significant cardiac dysfunction (e.g., congestive heart failure, myocardial ischemia, arrhythmias, poorly controlled high blood pressure, congenital long QT syndrome) within 12 months prior to Visit 1 or a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.