Comparison of VER-01 to Opioids in Patients With Chronic Non-specific Low Back Pain

NCT05610813 | Completed Phase 3

• 1 other identifier: VER-CLBP-002
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 2

Brief Summary

Randomized, open-label, parallel-group phase III trial to prove an additional benefit of the full-spectrum cannabis extract VER-01 over opioids in patients with chronic non-specific low back pain 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

Chronic Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Risk of developing constipation

  Number and proportion of constipation responders at the end of treatment phase (Visit 9). A constipation responder is defined as a patient with 1. a change from baseline (visit 2) in Bowel Function Index (BFI) total score of at least 15 points at Visit 9 and 2. a BFI total score of more than 28.8 at Visit 9.

  190 days

Secondary Outcomes (3)

• Efficacy based on pain reduction

  190 days

• Efficacy based on pain reduction in NE patients

  190 days

• Efficacy based on pain reduction and interference with sleep

  190 days

Study Arms (2)

Test intervention: VER-01

EXPERIMENTAL

VER-01 will be administered twice daily to patients randomized to treatment arm VER-01.

Drug: VER-01

Comparative intervention: Opioid therapy (with an authorised and marketed opioid, ATC code N02A)

ACTIVE COMPARATOR

Opioids will be administered according to the SmPC to patients randomized to treatment arm opioid therapy.

Drug: Opioid therapy

Interventions

VER-01 DRUG

Standardized oleoresin of Cannabis sativa L. folium cum flore, THC-chemotype (cannabis leaves and - flowers), corresponding to 21 mg (-)-trans-Δ9-Tetra-hydrocannabinol (THC) per gram drug product

Also known as: trans-Δ9-Tetra-hydrocannabinol (THC)

Test intervention: VER-01

Opioid therapy DRUG

The patient-specific selection of the marketed opioid (based on standard of care and provided for this study) is at the discretion of the investigator and made at Visit 1, i.e., before randomization at Visit 2.

Also known as: Opioids

Comparative intervention: Opioid therapy (with an authorised and marketed opioid, ATC code N02A)

Eligibility Criteria

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

You may qualify if:

• Male and female patients ≥18 years of age
• Provision of informed consent form voluntarily signed and dated by the patient
• For women of childbearing potential and men of reproductive potential: use of a reliable contraceptive method (Pearl index \< 1) at least 1 month before the start of the study and willingness to use it during the study participation and 3 months after the last intake of the test or comparative intervention
• Patient understands the local language and is willing and able to comply with scheduled visits, treatment plan, patient diary and other study related procedures throughout study participation
• Chronic (for at least 3 months) non-specific pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). Non-specific pain refers to pain without a clear specific treatable cause.
• Patients with indicated 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.
• Low back pain intensity on average at least 4 points on an 11-point Numeric Rating Scale in the last 4 weeks prior visit 1
• Ongoing non-drug pain therapy (physical or behavioral therapy) must have been stable for at least 2 weeks prior visit 1 and must be continued during the run-in phase
• Ongoing additional analgesic treatment prior visit 1 must be continued during the run-in phase
• Bowel Function Index total score of 28.8 or less at visit 1.

You may not qualify if:

• Patients with a known history of alcohol/drug/medication abuse or dependency and previous or current use of methadone
• Evidence of drugs of abuse or illegal drugs by urine drug test performed at visit 1
• Known intolerance or hypersensitivity to ingredients of rescue medication, opioid therapy (assigned by the investigator) and/or VER-01
• Participation in another clinical interventional study within the last 30 days prior screening visit (visit 1)
• Occupational groups with primary activity of operating machinery and driving motor vehicles
• Planned blood donation or planned donation or freezing of sperm or oocytes during study participation and 3 months after end of study participation
• Pregnant or breastfeeding female patients
• Patient is unable to provide written informed consent, in need for care, has a guardian/caretaker, is immobile, or is particularly vulnerable (e.g., imprisoned; institutionalised by a court or judicial authority; dependent or employed by the sponsor, an external service provider of the sponsor (involved in the conduct of the study), the investigator or the trial site)
• Known use of opioid or cannabis-based treatments within 30 days before screening visit (visit 1)
• Patients for whom cannabis or opioid therapy is not indicated, e.g., due to a history of non-response to opioid therapy or cannabis-based medicines in the treatment of chronic non-specific low back pain in the past.
• Start of or planned non-drug pain therapy during run-in phase (physical or behavioral therapy)
• Start or planned start of an additional analgesic treatment during run-in phase
• Ongoing monoamine oxidase inhibitor therapy at screening visit (visit 1)
• Patients with history of cancer in the last 5 years prior to screening visit (visit 1). Except for cutaneous basal cell or squamous cell cancer resolved by excision without recurrence and cervical cancer in situ resolved by excision with negative pap test.
• Painful comorbidities which could interfere with the low back pain intensity assessment during the study

Sponsors & Collaborators

• Vertanical GmbH: lead

Study Sites (2)

Rheumazentrum Prof. Dr. med. Gunther Neeck

Bad Doberan, 18209, Germany

Location

Medizinische Hochschule Hannover (MHH)

Hanover, 30625, Germany

Location

Related Publications (1)

• Meissner W, Argoff C, Sator S, Schoder V, Karst M. VER-01 Shows Enhanced Gastrointestinal Tolerability, Superior Pain Relief, and Improved Sleep Quality Compared to Opioids in Treating Chronic Low Back Pain: A Randomized Phase 3 Clinical Trial. Pain Ther. 2025 Dec;14(6):1765-1782. doi: 10.1007/s40122-025-00773-z. Epub 2025 Sep 30.

  PMID: 41028525 DERIVED

MeSH Terms

Interventions

Opiate Substitution Treatment; Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Matthias Karst, Prof.Dr.med.

  Medizinische Hochschule Hannover (MHH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: June 8, 2023
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)