Chronic Non-specific Low Back PainPhase 3NCT04940741
Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain
A Phase 3 study testing VER-01 in people with Chronic Non-specific Low Back Pain, run by Vertanical GmbH at 1 site in Germany.
Trial 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… 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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 820 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jul 2021to 26 Mar 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 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
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- 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
- b2. Patient wishes to participate voluntarily in the long-term study
- b3. From the investigator's point of view, further participation is considered medically safe
- b4. Willingness not to take any additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) during the last three weeks of study Phase B (except rescue medication).
- Additional for Phase C
- c1. Previous and complete participation in Phase B until and including Visit B10
- c2. Patient wishes to participate voluntarily in the long-term study
- c3. From the investigator's point of view, further participation is considered medically safe
- Additional for Phase D
- d1. Previous and complete participation in Phase B until and including Visit B10 (patients received Ver-01 for 26 weeks)
- d2. Patient has experienced a pain score improvement of at least 30% in treatment Phase B (mean value of the study week 43 compared to the mean value of the run-in phase, there must be at least four values from study week 43 and five values from the run-in phase)
- d3. Patient wishes to participate voluntarily in the study
- d4. From the investigator's point of view, further participation is considered medically safe
- d5. Willingness not to take any analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) during participation in study Phase D (except rescue medication)
- d6. Willingness to continue a current non-drug therapy unchanged as planned during study
Who cannot join
- 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
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- 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
- Pregnancy, breastfeeding, desire to have children (within the next 20 months)
- Participation in another clinical trial within the past 30 days before the start of the study
- Inability to give consent, care dependency, patient has a legal guardian/caregiver, or is immobile
- The patient is in need of special protection (e.g., incarcerated; institutionalized by a court or judicial authority; in a dependent or employment relationship with the sponsor, an external service provider of the sponsor (who is involved in the study conduct), the investigator, or the study site).
- Additional for Phase A:
- a1. In the case of a current non-drug therapy (e.g. physical or behavioural therapy, acupuncture,massage, thermotherapy), which significantly modulates the perception of pain, it was not maintained unchanged for at least eight weeks prior to study participation in Phase A.
- Additional for Phase D
- d1. Intake of additional analgesic medication (non-opioid and opioid analgesics as well as adjuvant analgesics) within 21 days prior to the start of study Phase D (except rescue medication).
- d2. In the case of a current non-drug therapy (e.g. physical or behavioural therapy, acupuncture,massage, thermotherapy) that significantly modulates the perception of pain, it was not maintained unchanged for at least nine weeks prior to the start of study Phase D.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of 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
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.
Read the detailed description
The study is divided into four phases: Phase A, B, C and D. All patients who have completed Phase A and for whom the investigator considers further participation to be safe shall begin Phase B. Phases C and D run in parallel, so that patients who have completed Phase B and for whom the investigator considers further participation to be safe can be assigned to one of the two phases.
Phases A and D follow a double-blind, placebo-controlled design, while Phase B and C have an open-label design.
The main goal of Phase A is to demonstrate the efficacy of VER-01 compared to placebo. In Phase B and C the main goal is the investigation of long-term safety of VER-01. In Phase D the primary objective is to demonstrate the maintenance of efficacy of VER-01 on a placebo-controlled basis.
The potential for dependence and abuse will be analyzed in all Phases (A,B,C,D), while the effect of abrupt drug withdrawal of VER-01 will be analyzed in Phase C and D.
- Conditions
- Chronic Non-specific Low Back Pain
- Being tested
- VER-01, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VER-01Drug
standardised cannabis extract (containing 21 mg THC per gram drug product)
PlaceboOther
comparator without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Absolute change compared to baseline (day1) Neuropathic Pain Symptom Inventory (NPSI) total score at the end of each treatment phase in patients with neuropathic pain
Measured: 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
Absolute changes from baseline in mean pain intensity at the end of each treatment phase measured in the morning (primary endpoint of Phase A) or morning and evening on an 11-point Numerical Rating Scale (NRS, where 0=no pain to 10=worst pain imaginable)
Measured: 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
The number and proportion of 30 percent and 50 percent pain responders in the morning, and morning and evening at the end of each treatment phase.
Measured: Baseline up to 72 weeks
Phases A, B, C and D: Sleep quality (NRS)
The absolute change from baseline in mean sleep quality at the end of each treatment phase measured on an 11-point Numerical Rating Scale (NRS, where 0=not impacted to 10=completely impacted)
Measured: Baseline up to 72 weeks
Phase A: Sleep quality (MOS-SS)
Absolute changes from baseline of sleep quality measured by Medical Outcomes Study Sleep Scale (MOS-SS) per survey point
Measured: Day 1, Day 22, Day 50, Day 78, Day 106
Phase A: Intake of rescue and concomitant medication
Cumulative dose of rescue medication taken in Phase A
Measured: Up to 16 weeks
Phase D: Intake of rescue and concomitant medication
Cumulative dose of rescue medication taken in Phase D
Measured: Up to 6 weeks
Phases A, B, C and D: Depression Anxiety Stress Scales (DASS)
Scores and absolute changes from baseline of depression, anxiety and stress levels measured by the DASS (where 0=did not apply to me at all to 3=affected me very greatly or most of the time) per time point of assessment
Measured: Baseline up to 72 weeks
Phases A, B, C and D: Global assessment of symptoms (patient global impression of change, PGIC)
Percentage of patients by category of the global assessment of symptoms (PGIC, 7-point Likert scale where 0=very much better to 6=very much worse) by the patient per survey point
Measured: Day 106, day 309, day 491, day 337
Phases A, B, C and D: Satisfaction with the treatment result - patient
Percentage of patients by category of the satisfaction with the treatment outcome (5-point Likert scale, where 0=very satisfied to 4=very unsatisfied) by the patient per survey point
Measured: Day 106, day 309, day 491, day 337
Phases A, B, C and D: Satisfaction with the treatment result - investigator
Percentage of patients by category of satisfaction with the treatment outcome (5-point Likert scale, where 0=very satisfied to 4=very unsatisfied) by the investigator per survey point.
Measured: Day 106, day 309, day 491, day 337
Phases A, B, C and D: Satisfaction with tolerability - patient
Percentage of patients by category of satisfaction with the tolerability (5-point Likert scale, where 0=very satisfied to 4=very unsatisfied) by the patient per survey point
Measured: Day 106, day 309, day 491, day 337
Phase A: Safety and adverse reactions
Safety and adverse reactions based on occurrence of treatment-related AEs/SAEs
Measured: Up to 16 weeks
Phase D: Safety and adverse reactions
Safety and adverse reactions based on occurrence of treatment-related AEs/SAEs
Measured: Up to 6 weeks
Phases A, B, C and D: Quality of life scores (Short Form 36, SF-36)
Scores in quality of life measured per survey point
Measured: Day 1, day 22, day 50, day 78, day 106, day 309, day 491, day 337
Phases A, B, C and D: Quality of life absolute changes (Short Form 36, SF-36)
Absolute changes in quality of life from baseline (day 1) measured per survey point
Measured: Day 1, day 22, day 50, day 78, day 106, day 309, day 491, day 337
Phase A: Scores in bodily function and impairment due to low back pain (Roland Morris Disability Questionnaire, RMD)
Scores in bodily function and impairment due to low back pain assessed by the RMD per survey point
Measured: Day 1, day 22, day 106
Phase A: Absolute changes in bodily function and impairment due to low back pain(Roland Morris Disability Questionnaire, RMD)
Absolute changes in bodily function and impairment due to low back pain assessed by the RMD per survey point
Measured: Day 1, day 22, day 106
Phases A, B, C and D: Addiction (Addiction Behaviors Checklist ,ABC)
The absolute number of positive answers of the ABC
Measured: Day 22, day 50, day 78, day 106, day 127, day 183, day 239, day 309, day 365, day 421, day 491, day 337
Phase C: Diagnosis of substance dependence ICD-10 (International Statistical Classification of Diseases and Related Health Problems)
The absolute number of positive answers according to the German Bundesärztekammer (2007) is summarized descriptively according to the standard for continuous parameters.
Measured: Day 491
Phase A, B, C and D: Adverse events (AEs)
Occurrence of AEs/SAEs
Measured: Through study completion, up to 72 weeks
Phase C: Withdrawal symptoms (Cannabis Withdrawal Scale, CWS)
Sum scores for intensity and functional impairment are descriptively analysed according to Allsop et al.
Measured: Up to 2 weeks
Phase D: Withdrawal symptoms (Cannabis Withdrawal Scale, CWS)
Sum scores for intensity and functional impairment are descriptively analysed according to Allsop et al.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start7 Jul 2021
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertanical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joachim Nadstawek, Prof., Principal investigator, Schmerzzentrum Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940741
- Sponsor's protocol ID
- VER-CLBP-001
- Status last verified
- Apr 2024
- First submitted
- 7 Jun 2021
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41023483
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of 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
- ClinicalTrials.gov ID
- NCT04940741
- Acronym / sponsor ID
- VER-CLBP-001
- Conditions
- Chronic Non-specific Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- Vertanical GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is divided into four phases: Phase A, B, C and D. All patients who have completed Phase A and for whom the investigator considers further participation to be safe shall begin Phase B. Phases C and D run in parallel, so that patients who have completed Phase B and for whom the investigator considers further participation to be safe can be assigned to one of the two phases.
Phases A and D follow a double-blind, placebo-controlled design, while Phase B and C have an open-label design.
The main goal of Phase A is to demonstrate the efficacy of VER-01 compared to placebo. In Phase B and C the main goal is the investigation of long-term safety of VER-01. In Phase D the primary objective is to demonstrate the maintenance of efficacy of VER-01 on a placebo-controlled basis.
The potential for dependence and abuse will be analyzed in all Phases (A,B,C,D), while the effect of abrupt drug withdrawal of VER-01 will be analyzed in Phase C and D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| VER-01 | Experimental | Drug: VER-01VER-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). |
| Placebo | Placebo comparator | Other: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VER-01standardised cannabis extract (containing 21 mg THC per gram drug product) | Drug | VER-01 |
| Placebocomparator without active ingredient | Other | Placebo |
Primary outcome
Phase A: Efficacy based on pain reduction
Time frame: Baseline up to 15 weeks
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).
Phase B: Safety based on occurrence of treatment-related AEs/SAEs
Time frame: Up to 29 weeks
Safety and adverse reactions based on occurrence of treatment-related AEs/SAEs
Phase C: Safety based on occurrence of treatment-related AEs/SAEs
Time frame: Up to 28 weeks
Safety and adverse reactions based on occurrence of treatment-related AEs/SAEs
Phase D: Maintenance of efficacy
Time frame: Up to 4 weeks (from date of randomization R2 until the first day of treatment failure)
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.
23 secondary outcomes
Phase A, B, C, D: Mean change in neuropathic pain
Time frame: 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
Time frame: 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
Time frame: Baseline up to 72 weeks
Phases A, B, C and D: Sleep quality (NRS)
Time frame: Baseline up to 72 weeks
Phase A: Sleep quality (MOS-SS)
Time frame: Day 1, Day 22, Day 50, Day 78, Day 106
Phase A: Intake of rescue and concomitant medication
Time frame: Up to 16 weeks
Phase D: Intake of rescue and concomitant medication
Time frame: Up to 6 weeks
Phases A, B, C and D: Depression Anxiety Stress Scales (DASS)
Time frame: Baseline up to 72 weeks
Phases A, B, C and D: Global assessment of symptoms (patient global impression of change, PGIC)
Time frame: Day 106, day 309, day 491, day 337
Phases A, B, C and D: Satisfaction with the treatment result - patient
Time frame: Day 106, day 309, day 491, day 337
Phases A, B, C and D: Satisfaction with the treatment result - investigator
Time frame: Day 106, day 309, day 491, day 337
Phases A, B, C and D: Satisfaction with tolerability - patient
Time frame: Day 106, day 309, day 491, day 337
Phase A: Safety and adverse reactions
Time frame: Up to 16 weeks
Phase D: Safety and adverse reactions
Time frame: Up to 6 weeks
Phases A, B, C and D: Quality of life scores (Short Form 36, SF-36)
Time frame: Day 1, day 22, day 50, day 78, day 106, day 309, day 491, day 337
Phases A, B, C and D: Quality of life absolute changes (Short Form 36, SF-36)
Time frame: Day 1, day 22, day 50, day 78, day 106, day 309, day 491, day 337
Phase A: Scores in bodily function and impairment due to low back pain (Roland Morris Disability Questionnaire, RMD)
Time frame: Day 1, day 22, day 106
Phase A: Absolute changes in bodily function and impairment due to low back pain(Roland Morris Disability Questionnaire, RMD)
Time frame: Day 1, day 22, day 106
Phases A, B, C and D: Addiction (Addiction Behaviors Checklist ,ABC)
Time frame: Day 22, day 50, day 78, day 106, day 127, day 183, day 239, day 309, day 365, day 421, day 491, day 337
Phase C: Diagnosis of substance dependence ICD-10 (International Statistical Classification of Diseases and Related Health Problems)
Time frame: Day 491
Phase A, B, C and D: Adverse events (AEs)
Time frame: Through study completion, up to 72 weeks
Phase C: Withdrawal symptoms (Cannabis Withdrawal Scale, CWS)
Time frame: Up to 2 weeks
Phase D: Withdrawal symptoms (Cannabis Withdrawal Scale, CWS)
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 41023483Karst 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Nadstawek, Prof. principal investigator
Schmerzzentrum Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VER-01 in people with Chronic Non-specific Low Back Pain, run by Vertanical GmbH at 1 site 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 29 inclusion and 24 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 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Phase A: Efficacy based on pain reduction (time frame: Baseline up to 15 weeks). The study lists 4 primary outcomes in all. 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 NCT04940741, 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 8 Apr 2024.