NCT06956014

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

Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of the Full-spectrum Cannabis Extract VER-01 in Patients With Radicular Chronic Low Back Pain

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 810 (estimated)
• Sponsor: Vertanical GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radicular Low Back Pain

Interventions

Type	Name	Description
DRUG	VER-01	Standardized soft extract from Cannabis sativa DKJ127 L., cannabis flos (Cannabis flower), corresponding to 19 mg Δ9-Tetrahydrocannabinol (THC) per ml drug product
OTHER	Placebo	Comparator without active ingredient

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-05-02
• Last updated: 2026-03-13

Regulatory

• FDA-regulated drug study