AzTrials
AzTrials

Chronic Non-specific Low Back PainPhase 3ELEVATENCT05610813

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

A Phase 3 study testing VER-01 and Opioid therapy in people with Chronic Non-specific Low Back Pain, run by Vertanical GmbH at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Non-specific Low Back Pain
What is being tested?
VER-01 and Opioid therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
384 participants
Where
2 sitesGermany
Study dates
8 Jun 2023to 18 Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 29Show fewer
  • 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
  • Known history of human immunodeficiency virus (HIV) infection
  • Severe forms of the following diseases: Anaemia, haematological / autoimmune / endocrine / renal / hepatic / respiratory / cardiovascular / neurological / gastrointestinal / symptomatic peripheral vascular diseases.
  • Cardiovascular event in the last three months before screening visit (visit 1)
  • Known uncontrolled hypertension (average systolic blood pressure ≥140 mmHg or average diastolic blood pressure
  • ≥90 mmHg) and/or untreated hypothyroidism
  • Patients with Crigler-Najjar syndrome, Rotor syndrome and/or porphyria
  • History of major trauma or back surgery in the last 2 months prior to screening visit (visit 1)
  • Known history of or current severe psychiatric illness
  • Known history of or current severe depression (not due to chronic low back pain) (assessed by Patient Health Questionnaire - 9) and/or suicidal ideation (assessed by Columbia-Suicide Severity Rating Scale) at screening visit (visit 1)
  • Patients with severe respiratory depression
  • Patients with lung disease associated with impaired lung function (e.g., acute or severe bronchial asthma or hypercapnia/respiratory failure).
  • Patients with conditions of increased intracranial pressure due to head injury or disease of the brain.
  • Patients with existing or suspected paralytic ileus
  • Patients with intestinal obstruction due to intestinal paralysis

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Rheumazentrum Prof. Dr. med. Gunther Neeck

    Bad Doberan, 18209

  • Medizinische Hochschule Hannover (MHH)

    Hanover, 30625

Other trials in Germany

About this study

Official title: Multicentre, Randomized, Open-label Study to Prove an Additional Benefit of the Full-spectrum Cannabis Extract VER-01 Over Opioids in the Treatment of Patients With Chronic Non-specific Low Back Pain

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.

Read the detailed description

The test intervention VER-01 is a cannabis-based pain medication currently under clinical development that is expected to provide adequate pain relief while being better tolerated in long-term treatment compared to opioid analgesics. This study aims to demonstrate the superior tolerability, especially in terms of bowel function, of VER-01 compared to existing authorised and marketed opioid analgesics in patients with chronic non-specific low back pain. In addition, the safety and tolerability as well as the efficacy of VER-01 compared to opioid therapy will be evaluated.

Being tested
VER-01, Opioid therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VER-01Drug

    Also called trans-Δ9-Tetra-hydrocannabinol (THC)

    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

  • Opioid therapyDrug

    Also called Opioids

    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.

Study groups in NCT05610813
Study groupRoleWhat they receive
Test intervention: VER-01ExperimentalVER-01 will be administered twice daily to patients randomized to treatment arm VER-01.
Receives: Drug: VER-01
Comparative intervention: Opioid therapy (with an authorised and marketed opioid, ATC code N02A)Active comparatorOpioids will be administered according to the SmPC to patients randomized to treatment arm opioid therapy.
Receives: Drug: Opioid therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 190 days

Secondary outcomes (3)

  1. Efficacy based on pain reduction

    Number and percentage of 30% pain responders at study week 27 (last week of treatment phase) compared with the baseline score (study week -1)

    Measured: 190 days

  2. Efficacy based on pain reduction in NE patients

    Number and percentage of 30% pain responders in the subgroup of patients with a neuropathic pain component (painDETECT score >18) at study week 27 compared with the baseline score (study week -1)

    Measured: 190 days

  3. Efficacy based on pain reduction and interference with sleep

    Number and percentage of patients with a 30% improvement of the mean daily low back pain interference with sleep score evaluated on an 11-point Numeric Rating Scale (NRS) at study week 27 compared with the baseline score (study week -1)

    Measured: 190 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2022
  2. Study start8 Jun 2023
  3. Primary completion18 Oct 2024
  4. Study completion18 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610813
Sponsor's protocol ID
VER-CLBP-002
Acronym
ELEVATE
Status last verified
Nov 2024
First submitted
2 Nov 2022
Last updated
25 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41028525

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VER-01 and Opioid therapy in people with Chronic Non-specific Low Back Pain, run by Vertanical GmbH at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk of developing constipation (time frame: 190 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05610813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in