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

Multicenter, Double-blind, Randomized, Placebo-controlled, Dose Response Trial With the Full-spectrum Cannabis Extract VER-01 in Patients With Chronic Non-specific Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Non-specific Low Back Pain
• Intervention / Treatment: Drug: VER-01; Drug: Placebo

Detailed Description

The primary objective of this multicenter, double-blind, randomized, placebo-controlled trial is to characterize the dose-response relationship of VER-01 in terms of pain reduction in patients with chronic non-specific low back pain.

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.

The secondary objectives are to evaluate the efficacy using additional outcome measures, the safety and the tolerability of VER-01 compared to placebo.

• Study Type: Interventional
• Enrollment (Actual): 652
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • St Pancras Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient meets the Quebec Task Force (QTF) classification system of categories 1 to 3 of low back pain
2. Male and female patients ≥ 18 years of age
3. Provision of informed consent form (ICF) voluntarily signed and dated by the patient
4. 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
5. 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
6. 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
7. 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
8. Low back pain intensity on average ≥ 4 points on an 11-point NRS in the last 4 weeks prior Visit 1
9. 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
10. 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

Exclusion Criteria:

1. 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
2. Evidence of drugs of abuse or illegal drugs by urine drug test performed at Visit 1
3. Known intolerance or hypersensitivity to ingredients of rescue medication, VER-01, and/or placebo (e.g., sesame oil)
4. Participation in another clinical interventional trial within the last 30 days prior Visit 1 or previous participation in a trial for VER-01
5. Occupational groups with primary activity of operating machinery and driving motor vehicles
6. 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
7. Pregnant or breastfeeding female patients
8. 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)
9. Known use of THC-containing drugs within 30 days prior Visit 1
10. Patients deemed non-responsive to cannabis treatment due to medical history
11. Start of or planned start of an analgesic treatment or non-drug therapy, that significantly modulates pain perception, during trial participation
12. Planned surgery or other invasive procedure that requires analgetic treatment or might cause pain that could interfere with the low back pain intensity assessment
13. 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
14. Painful comorbidities which could interfere with the low back pain intensity assessment during the trial
15. Known history of human immunodeficiency virus (HIV) infection
16. Severe forms of the following diseases: anaemia, haematological/autoimmune/ endocrine/renal/hepatic/respiratory/cardiovascular/neurological/gastrointestinal/ symptomatic peripheral vascular diseases
17. Cardiovascular event in the last 3 months prior Visit 1
18. Poorly managed high blood pressure and/or untreated hypothyroidism
19. Patients with bilirubin metabolic disorder (e.g., Crigler-Najjar syndrome, Rotor syndrome)
20. Known history of major trauma or back surgery in the last 6 months prior Visit 1)
21. Known history of previous or current severe psychiatric illness Examples (not fully exhaustive) for severe psychiatric illness are: Bipolar (I or II) disorder, schizophrenia, manic episode, hypomanic episode, post-traumatic stress disorder, panic disorder, any psychotic disorder
22. Known history of previous or current severe depression (not due to chronic low back pain) and/or suicidal ideation at Visit 1
23. Known history of previous or current epilepsy or seizure disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VER-01; 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; 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.
Placebo Comparator: Placebo; Placebo is administered orally (b.i.d.) using a dosing syringe. The patient is assigned a fixed dose according to their cohort.	Drug: Placebo; Comparator without active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain responders	Number and percentage of 30% and 50% pain responders	End of the Treatment Phase (Week 7) compared to Baseline (Week -1)
PGIC	Percentage of patients by answer category ('Improved', 'Not improved') of the global assessment of symptoms (PGIC, 7-point Likert scale where 0=very much better to 6=very much worse)	At the end of the Treatment Phase (Week 7)
Safety: TEAEs and TESAEs	Occurrence of treatment-emergent adverse events (TEAEs)/treatment-emergent serious adverse events (TESAEs)	Week 1 up to Week 13
Satisfaction with tolerability	Percentage of patients by answer category ("satisfied", "unsatisfied") based on the satisfaction of the patient with tolerability (5-point Likert scale, where 0=very satisfied to 4=very unsatisfied)	At the end of the Treatment Phase (Week 7)

Collaborators and Investigators

• Sponsor: Vertanical GmbH
• Investigators: Principal Investigator: Martin Johnson, Dr., St Pancras Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Pain; Back Pain; Neuropathic Pain; Back Pain Lower Back Chronic; Back Pain, Low
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: VER-CLBP-004; 2023-507358-34 (EudraCT Number); 1008617 (Other Identifier: IRAS ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No