NCT06475001

Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

Multicenter, Double-blind, Randomized, Placebo-controlled, Dose Response Trial With the Full-spectrum Cannabis Extract VER-01 in Patients With Chronic Non-specific Low Back Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 652 (actual)
• Sponsor: Vertanical GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dose-response characterization of VER-01 in patients with chronic non-specific low back pain (CLBP) 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.

Detailed description

The primary objective of this multicenter, double-blind, randomized, placebo-controlled trial is to characterize the dose-response relationship of VER-01 in terms of pain reduction in patients with chronic non-specific low back pain. Eligible patients are randomized to one of four different dose groups (cohorts) in a 1:1:1:1 ratio and either active drug (VER-01) or placebo. The secondary objectives are to evaluate the efficacy using additional outcome measures, the safety and the tolerability of VER-01 compared to placebo.

Conditions

• Chronic Non-specific Low Back Pain

Interventions

Type	Name	Description
DRUG	VER-01	Herbal medicinal product, containing as active substance a soft extract of Cannabis sativa L., cannabis flos (Cannabis flower), adjusted to a content of 50 mg/g delta-9-tetrahydrocannabinol (THC). VER-01 is adjusted to a concentration of 19 mg/mL THC by adding the excipient sesame oil.
DRUG	Placebo	Comparator without active ingredient

Timeline

• Start date: 2024-06-28
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2024-06-26
• Last updated: 2025-08-11

Locations

1 site across 1 country: United Kingdom