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

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.

Timeline

Start

2021-07-07

Primary completion

2024-03-26

Completion

2024-03-26

Outcome

Mixed primary results

paper The study met its primary endpoint in phase A, with a mean pain reduction of -1.9 NRS points in the VER-01 group PMID 41023483 ↗

paper Although phase D did not meet its primary endpoint (hazard ratio = 0.75, 95% CI = 0.44-1.27; P = 0.288) PMID 41023483 ↗

Publications

• Karst M, Meissner W, Sator S, Kessler J, Schoder V, Hauser W. Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. Nat Med. 2025 Dec;31(12):4189-4196. doi: 10.1038/s41591-025-03977-0. Epub 2025 Sep 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	VER-01	Unknown	2.5 mg	Oral

Indications

No indication recorded.