Efficacy and Safety of VER-01 in the Treatment of Patients With Radicular Chronic Low Back Pain (EXPAND)

Vertanical

Status and phase: Begins enrollment in 3 months; Phase 3

Conditions: Radicular Low Back Pain

Treatments: Drug: VER-01; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06956014

VER-CLBP-003

Details and patient eligibility

About

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.

Enrollment: 810 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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810 participants in 3 patient groups, including a placebo group

VER-01 corresponding to 22.5 mg THC

Experimental group

Treatment:

Drug: VER-01

VER-01 corresponding to 32.5 mg THC

Experimental group

Treatment:

Drug: VER-01

Placebo

Placebo Comparator group

Treatment:

Other: Placebo