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

NCT06956014 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: VER-CLBP-003
• Study Type: interventional
• Target: 810
• Locations: 0 countries
• Sites: N/A

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) 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.

Conditions

Radicular Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Efficacy based on pain reduction

  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).

  From Baseline to Treatment Week 12

Study Arms (3)

VER-01 corresponding to 22.5 mg THC

EXPERIMENTAL

Drug: VER-01

VER-01 corresponding to 32.5 mg THC

EXPERIMENTAL

Drug: VER-01

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

VER-01 DRUG

Standardized soft extract from Cannabis sativa DKJ127 L., cannabis flos (Cannabis flower), corresponding to 19 mg Δ9-Tetrahydrocannabinol (THC) per ml drug product

VER-01 corresponding to 22.5 mg THC; VER-01 corresponding to 32.5 mg THC

Placebo OTHER

Comparator without active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vertanical GmbH: lead

Central Study Contacts

Vertanical GmbH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share