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

NCT04940741 | Completed Phase 3

• 1 other identifier: VER-CLBP-001
• Study Type: interventional
• Target: 820
• Locations: 1 country
• Sites: 1

Brief Summary

Analysis of the efficacy, maintenance of efficacy, long-term safety, and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised 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 (4)

• Phase A: Efficacy based on pain reduction

  Change in average pain intensity compared to baseline on an 11-point Numerical Rating Scale (NRS, where 0=no pain to 10=worst pain imaginable) (mean value of study week 15 compared to the mean value of the seven-day run-in phase with daily documentation of pain intensity in the morning).

  Baseline up to 15 weeks

• Phase B: Safety based on occurrence of treatment-related AEs/SAEs

  Safety and adverse reactions based on occurrence of treatment-related AEs/SAEs

  Up to 29 weeks

• Phase C: Safety based on occurrence of treatment-related AEs/SAEs

  Safety and adverse reactions based on occurrence of treatment-related AEs/SAEs

  Up to 28 weeks

• Phase D: Maintenance of efficacy

  Time until treatment failure defined as the time in days from randomization to phase D (R2) until the first day of treatment failure. Treatment failure is assessed by the daily calculated seven-day mean value of the pain score (11 point Numerical Rating Scale, NRS, where 0=no pain to 10=worst pain imaginable) in the morning during the treatment period, which must have deteriorated by at least 20% and at least one point compared to baseline (mean value of study week 43). The first day of treatment failure is then the earliest day within this seven-day time window to which this criterion applies as a single day. Furthermore, treatment failure is defined as a premature discontinuation of treatment for selected reasons.

  Up to 4 weeks (from date of randomization R2 until the first day of treatment failure)

Secondary Outcomes (23)

• Phase A, B, C, D: Mean change in neuropathic pain

  Day 1, day 106, day 309, day 351, day 505

• Phase A, B, C, D: Change in pain intensity in the morning, as well as in the morning and evening

  Baseline up to 72 weeks

• Phases A, B, C and D: Pain responders (30 percent and 50 percent) in the morning, as well as in the morning and evening

  Baseline up to 72 weeks

• Phases A, B, C and D: Sleep quality (NRS)

  Baseline up to 72 weeks

• Phase A: Sleep quality (MOS-SS)

  Day 1, Day 22, Day 50, Day 78, Day 106

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 optimal dose is titrated on a patient-by-patient basis. The maximum daily dose should not exceed 13 dose units (32.5 mg THC).

Drug: VER-01

Placebo

PLACEBO COMPARATOR

The Placebo is administered orally (b.i.d.) using a dosing syringe. The optimal dose is titrated on a patient-by-patient basis, analogous to VER-01.

Other: Placebo

Interventions

VER-01 DRUG

standardised cannabis extract (containing 21 mg THC per gram drug product)

VER-01

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:

• Male and female patients (18 years and older)
• Chronic (for at least three months) non-specific pain in the lower back (between the lower ribcage and the gluteal folds)
• Pain intensity on average at least 4 points on an 11-point NRS (one month before the start of the study)
• Patients with indicated drug treatment where previous optimised treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.
• Willingness of both men and women to use a reliable method of contraception during study participation and for three months after taking the last dose of the IMP
• Signed patient information and informed consent form is available
• Understanding of the German language, ability to give consent and compliance
• The patient has understood the instructions to avoid changes in lifestyle and dietary habits
• The patient has understood the principle of the patient diary and gives their consent to keep it as instructed
• Additional for Phase A
• a1. Pain intensity averaged at least 4 points on an 11-point NRS (there must be at least 5 pain intensity readings in the morning from the run-in phase)
• a2. Willingness not to take any analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) during participation in study Phase A (except rescue medication)
• a3. Willingness to continue a current non-drug therapy unchanged as planned during participation in Phase A
• Additional for Phase B
• b1. Previous and complete participation in Phase A until and including Visit A6

You may not qualify if:

• Professional groups for which the ability to operate machinery and drive vehicles is the primary activity (including truck, bus and forklift drivers, pilots)
• Alcohol/drug/medication abuse and previous or current intake of methadone in the patient's medical history or suspected by the investigator
• Intake of analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) within seven days prior to the start of the study
• Taking cannabis-based products within 30 days prior to the start of the study
• HIV, dementia (which impairs the assessment of symptoms)
• Severe forms of the following diseases: Anaemia,hematological/autoimmune/endocrinal/ renal/hepatic/respiratory/cardiovascular or gastrointestinal diseases, symptomatic peripheral vascular diseases
• Cardiovascular event in the past three months, poorly managed high blood pressure, untreated hypothyroidism, patients with Crigler-Najjar syndrome or Rotor syndrome, surgery within the past two months
• Severe mental illnesses (e.g. psychosis, schizophrenia, bipolar disorder), severe depression that is not due to the chronic non-specific low back pain, or individuals at risk of suicide (examined using the MINI questionnaire)
• Severe mental illness (psychosis, schizophrenia, bipolar disorder, severe depression, anxiety disorder) in a first-degree relative (parents and children); suicide in a first-degree relative (parents and children)
• Patients with an active cancer or tumor-related pain or severe pain due to physical injury
• Other painful comorbidities, excluding low back pain, that could interfere with the patient's evaluation during the study or the assessment of pain
• Well-known strong adverse events in connection with cannabis consumption before the start of the study
• Known allergy to cannabis and/or sesame seeds and products derived from them
• Known hypersensitivity to the ingredients of the rescue medication
• Planned blood donation, planned sperm or egg donation, planned freezing of eggs or sperm

Sponsors & Collaborators

• Vertanical GmbH: lead

Study Sites (1)

Emovis GmbH

Berlin, 10629, Germany

Location

Related Publications (1)

• Karst M, Meissner W, Sator S, Kessler J, Schoder V, Hauser W. Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. Nat Med. 2025 Dec;31(12):4189-4196. doi: 10.1038/s41591-025-03977-0. Epub 2025 Sep 29.

  PMID: 41023483 DERIVED

Study Officials

• Joachim Nadstawek, Prof.

  Schmerzzentrum Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: different phases: open-label treatment and randomised, double-blind, placebo-controlled treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase A: randomised, double-blind, placebo-controlled (Efficacy and safety) Phase B: Open-label treatment (long-term safety) Phase C: Open-label treatment (long-term safety) Phase D: randomised, double-blind, placebo-controlled (maintenance of efficacy)

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 28, 2021
• Study Start: July 7, 2021
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)