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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
810
Efficacy based on pain reduction
The primary endpoint is the absolute change in mean CLBP intensity measured on an 11-point numerical rating scale (NRS) at Treatment Week 12 compared to Baseline (Study Week -1).
Time frame: From Baseline to Treatment Week 12
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