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Efficacy and Safety of VER-01 in the Treatment of Patients With Radicular Chronic Low Back Pain | Clinical Trials | Clareo Health

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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

NCT06956014•Vertanical GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
•Participant meets the Quebec Task Force (QTF) classification system of category 3 of low back pain
•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.

Key Dates

Start Date

September 1, 2026

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2027

Last Updated

March 13, 2026

Enrollment

810

ESTIMATED participants

Conditions

Radicular Low Back Pain

Interventions

VER-01

DRUG

Placebo

OTHER

Contacts

Vertanical GmbH

CONTACT

+49 (0)89 787 97 90 - 0202 regulatory@vertanical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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