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

NCT ID: NCT06475001

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 652 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2025-07-31

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.

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.

Conditions

Chronic Non-specific Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

VER-01

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Comparator without active ingredient

Interventions

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.

Intervention Type: DRUG

Placebo

Comparator without active ingredient

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertanical GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Johnson, Dr.

Role: PRINCIPAL_INVESTIGATOR

St Pancras Clinical Research

Locations

St Pancras Clinical Research

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2023-507358-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1008617

Identifier Type: OTHER

Identifier Source: secondary_id

VER-CLBP-004

Identifier Type: -

Identifier Source: org_study_id