NCT04940741

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

Proof of Efficacy, Maintenance of Efficacy, Long-term Safety and Investigation of the Potential for Dependence and Abuse and the Effect of Abrupt Drug Withdrawal of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 820 (actual)
• Sponsor: Vertanical GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Analysis of the efficacy, maintenance of efficacy, long-term safety, and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.

Detailed description

The study is divided into four phases: Phase A, B, C and D. All patients who have completed Phase A and for whom the investigator considers further participation to be safe shall begin Phase B. Phases C and D run in parallel, so that patients who have completed Phase B and for whom the investigator considers further participation to be safe can be assigned to one of the two phases. Phases A and D follow a double-blind, placebo-controlled design, while Phase B and C have an open-label design. The main goal of Phase A is to demonstrate the efficacy of VER-01 compared to placebo. In Phase B and C the main goal is the investigation of long-term safety of VER-01. In Phase D the primary objective is to demonstrate the maintenance of efficacy of VER-01 on a placebo-controlled basis. The potential for dependence and abuse will be analyzed in all Phases (A,B,C,D), while the effect of abrupt drug withdrawal of VER-01 will be analyzed in Phase C and D.

Conditions

• Chronic Non-specific Low Back Pain

Interventions

Type	Name	Description
DRUG	VER-01	standardised cannabis extract (containing 21 mg THC per gram drug product)
OTHER	Placebo	comparator without active ingredient

Timeline

• Start date: 2021-07-07
• Primary completion: 2024-03-26
• Completion: 2024-03-26
• First posted: 2021-06-28
• Last updated: 2024-04-08

Locations

1 site across 1 country: Germany