Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain

NCT06475001 | Completed Phase 2

• 3 other identifiers: VER-CLBP-0042023-507358-341008617
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

Brief Summary

Dose-response characterization of VER-01 in patients with chronic non-specific 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.

Conditions

Chronic Non-specific Low Back Pain

Keywords

Chronic Pain; Neuropathic Pain; Back Pain; Back Pain, Low; Back Pain Lower Back Chronic

Outcome Measures

Primary Outcomes (1)

• Efficacy based on pain reduction

  Change in mean pain intensity measured on an 11-point numerical rating scale (NRS)

  End of the Treatment Phase (Week 7) compared to Baseline (Week -1)

Secondary Outcomes (4)

• Pain responders

  End of the Treatment Phase (Week 7) compared to Baseline (Week -1)

• PGIC

  At the end of the Treatment Phase (Week 7)

• Safety: TEAEs and TESAEs

  Week 1 up to Week 13

• Satisfaction with tolerability

  At the end of the Treatment Phase (Week 7)

Study Arms (2)

VER-01

EXPERIMENTAL

VER-01 is administered orally (b.i.d.) using a dosing syringe. One unit corresponds to 2.5 mg THC. The patient is assigned a fixed dose according to their cohort.

Drug: VER-01

Placebo

PLACEBO COMPARATOR

Placebo is administered orally (b.i.d.) using a dosing syringe. The patient is assigned a fixed dose according to their cohort.

Drug: Placebo

Interventions

VER-01 DRUG

Herbal medicinal product, containing as active substance a soft extract of Cannabis sativa L., cannabis flos (Cannabis flower), adjusted to a content of 50 mg/g delta-9-tetrahydrocannabinol (THC). VER-01 is adjusted to a concentration of 19 mg/mL THC by adding the excipient sesame oil.

VER-01

Placebo DRUG

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:

• Patient meets the Quebec Task Force (QTF) classification system of categories 1 to 3 of low back pain
• Male and female patients ≥ 18 years of age
• Provision of informed consent form (ICF) voluntarily signed and dated by the patient
• For female patients of childbearing potential and male patients of reproductive potential: use of a reliable contraceptive method (Pearl index \< 1) at least 1 month before the screening visit and willingness to use it during the trial 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, eDiary, and other trial-related procedures throughout trial participation
• Chronic (≥ 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 somatic cause, for which targeted therapy can have a positive effect on the course of the disease. Such somatic causes are e.g., herniated vertebral disk, spinal canal stenosis, inflammatory back pain, osteoporosis, fracture, infection, tumor, spondylolisthesis
• 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
• Low back pain intensity on average ≥ 4 points on an 11-point NRS in the last 4 weeks prior Visit 1
• In case of non-drug therapy in the 4 weeks prior to Visit 1 (e.g., exercise or behavioral therapy, acupuncture, massage, thermotherapy) that significantly modulates pain perception: the non-drug therapy was unchanged and is still ongoing at Visit 1 and all requirements for continuation of the therapy throughout the trial are given (e.g., prescription, patient's compliance). Ongoing non-drug therapies should be continued unchanged during trial participation
• Willingness to not take or use any prohibited medication during trial participation. The intake or use of any additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics and muscle relaxants), during trial participation is prohibited (except rescue medication). Likewise, strong inhibitors, substrates, or inducers of CYP2C9 and CYP3A4 are considered prohibited concomitant medication in this trial

You may not qualify if:

• Patients with a known history of alcohol/drug/medication abuse (except nicotine) or any dependency or addiction (physical or behavioral) 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, VER-01, and/or placebo (e.g., sesame oil)
• Participation in another clinical interventional trial within the last 30 days prior Visit 1 or previous participation in a trial for VER-01
• Occupational groups with primary activity of operating machinery and driving motor vehicles
• Planned blood donation, planned pregnancy, or planned donation or freezing of sperm or oocytes during trial participation and 3 months after end of trial 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; institutionalized by an administrative or judicial authority; dependent or employed by the Sponsor, an external service provider of the Sponsor (involved in the conduct of the trial), the investigator, or the trial site)
• Known use of THC-containing drugs within 30 days prior Visit 1
• Patients deemed non-responsive to cannabis treatment due to medical history
• Start of or planned start of an analgesic treatment or non-drug therapy, that significantly modulates pain perception, during trial participation
• Planned surgery or other invasive procedure that requires analgetic treatment or might cause pain that could interfere with the low back pain intensity assessment
• Patients with history of cancer in the last 5 years prior 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 trial
• Known history of human immunodeficiency virus (HIV) infection

Sponsors & Collaborators

• Vertanical GmbH: lead

Study Sites (1)

St Pancras Clinical Research

London, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Martin Johnson, Dr.

  St Pancras Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible patients are randomized to one of four different dose groups (cohorts) in a 1:1:1:1 ratio and either active drug (VER-01) or placebo.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 26, 2024
• Study Start: June 28, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)