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

November 21, 2024 updated by: Vertanical GmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
384

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Doberan, Germany, 18209
        • Rheumazentrum Prof. Dr. med. Gunther Neeck
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover (MHH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female patients ≥18 years of age
  2. Provision of informed consent form voluntarily signed and dated by the patient
  3. 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
  4. 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
  5. 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.
  6. 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.
  7. 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
  8. 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
  9. Ongoing additional analgesic treatment prior visit 1 must be continued during the run-in phase
  10. Bowel Function Index total score of 28.8 or less at visit 1.

Exclusion Criteria:

  1. Patients with a known history of alcohol/drug/medication abuse or dependency 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, opioid therapy (assigned by the investigator) and/or VER-01
  4. Participation in another clinical interventional study within the last 30 days prior screening visit (visit 1)
  5. Occupational groups with primary activity of operating machinery and driving motor vehicles
  6. Planned blood donation or planned donation or freezing of sperm or oocytes during study participation and 3 months after end of study 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; 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)
  9. Known use of opioid or cannabis-based treatments within 30 days before screening visit (visit 1)
  10. 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.
  11. Start of or planned non-drug pain therapy during run-in phase (physical or behavioral therapy)
  12. Start or planned start of an additional analgesic treatment during run-in phase
  13. Ongoing monoamine oxidase inhibitor therapy at screening visit (visit 1)
  14. 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.
  15. Painful comorbidities which could interfere with the low back pain intensity assessment during the study
  16. Known history of human immunodeficiency virus (HIV) infection
  17. Severe forms of the following diseases: Anaemia, haematological / autoimmune / endocrine / renal / hepatic / respiratory / cardiovascular / neurological / gastrointestinal / symptomatic peripheral vascular diseases.
  18. Cardiovascular event in the last three months before screening visit (visit 1)

  19. Known uncontrolled hypertension (average systolic blood pressure ≥140 mmHg or average diastolic blood pressure

    ≥90 mmHg) and/or untreated hypothyroidism

  20. Patients with Crigler-Najjar syndrome, Rotor syndrome and/or porphyria
  21. History of major trauma or back surgery in the last 2 months prior to screening visit (visit 1)
  22. Known history of or current severe psychiatric illness
  23. 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)
  24. Patients with severe respiratory depression
  25. Patients with lung disease associated with impaired lung function (e.g., acute or severe bronchial asthma or hypercapnia/respiratory failure).
  26. Patients with conditions of increased intracranial pressure due to head injury or disease of the brain.
  27. Patients with existing or suspected paralytic ileus
  28. Patients with intestinal obstruction due to intestinal paralysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test intervention: VER-01
VER-01 will be administered twice daily to patients randomized to treatment arm VER-01.
Drug: VER-01
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
Other Names:
  • trans-Δ9-Tetra-hydrocannabinol (THC)
Active Comparator: Comparative intervention: Opioid therapy (with an authorised and marketed opioid, ATC code N02A)
Opioids will be administered according to the SmPC to patients randomized to treatment arm opioid therapy.
Drug: Opioid therapy
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.
Other Names:
  • Opioids

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Risk of developing constipation
Time Frame: 190 days

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.
190 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy based on pain reduction
Time Frame: 190 days
Number and percentage of 30% pain responders at study week 27 (last week of treatment phase) compared with the baseline score (study week -1)
190 days
Efficacy based on pain reduction in NE patients
Time Frame: 190 days
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)
190 days
Efficacy based on pain reduction and interference with sleep
Time Frame: 190 days
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)
190 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vertanical GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthias Karst, Prof.Dr.med., Medizinische Hochschule Hannover (MHH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VER-CLBP-002

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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