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

Phase 3

Not yet recruiting

• Conditions: Chronic Low Back Pain
• Interventions: Drug: VER-01; Other: Placebo

• Registration Number: NCT06956014
• Lead Sponsor: Vertanical GmbH

Brief 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) 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

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-05-02
• Last Update Posted: 2025-05-02
• Study Start: 2025-11
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 700

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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VER-01 corresponding to 22.5 mg THC	VER-01	-
VER-01 corresponding to 32.5 mg THC	VER-01	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Efficacy based on pain reduction	From Baseline to Treatment Week 12	The primary endpoint is the absolute change in mean CLBP intensity measured on an 11-point numerical rating scale (NRS) at Treatment Week 12 compared to Baseline (Study Week -1).