Chronic Non-specific Low Back PainPhase 2RESPONSENCT06475001
Dose-Response Characterization of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain
A Phase 2 study testing VER-01 in people with Chronic Non-specific Low Back Pain, run by Vertanical GmbH at 1 site in United Kingdom.
Trial 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. 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
- 652 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2024to 31 Jul 2025
- Phase
- Phase 2
- 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
- Patient meets the Quebec Task Force (QTF) classification system of categories 1 to 3 of low back pain
- Male and female patients ≥ 18 years of age
- Provision of informed consent form (ICF) voluntarily signed and dated by the patient
- 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
- 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
- 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
Show all 10Show fewer
- 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
- Low back pain intensity on average ≥ 4 points on an 11-point NRS in the last 4 weeks prior Visit 1
- 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
- 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
Who cannot join
- 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
- 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, VER-01, and/or placebo (e.g., sesame oil)
- Participation in another clinical interventional trial within the last 30 days prior Visit 1 or previous participation in a trial for VER-01
- Occupational groups with primary activity of operating machinery and driving motor vehicles
- 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
Show all 23Show 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; 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)
- Known use of THC-containing drugs within 30 days prior Visit 1
- Patients deemed non-responsive to cannabis treatment due to medical history
- Start of or planned start of an analgesic treatment or non-drug therapy, that significantly modulates pain perception, during trial participation
- Planned surgery or other invasive procedure that requires analgetic treatment or might cause pain that could interfere with the low back pain intensity assessment
- 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
- Painful comorbidities which could interfere with the low back pain intensity assessment during the trial
- 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 3 months prior Visit 1
- Poorly managed high blood pressure and/or untreated hypothyroidism
- Patients with bilirubin metabolic disorder (e.g., Crigler-Najjar syndrome, Rotor syndrome)
- Known history of major trauma or back surgery in the last 6 months prior Visit 1)
- 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
- Known history of previous or current severe depression (not due to chronic low back pain) and/or suicidal ideation at Visit 1
- Known history of previous or current epilepsy or seizure disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled, Dose Response Trial With the Full-spectrum Cannabis Extract VER-01 in Patients With Chronic Non-specific Low Back Pain
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.
Read the 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
- Being tested
- VER-01, Placebo
- Keywords
- Chronic Pain, Neuropathic Pain, Back Pain, Back Pain, Low, Back Pain Lower Back Chronic
- Medical subject headings
- Chronic Pain, Neuralgia, Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VER-01Drug
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.
PlaceboDrug
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 patient is assigned a fixed dose according to their cohort. Receives: Drug: VER-01 |
| Placebo | Placebo comparator | Placebo is administered orally (b.i.d.) using a dosing syringe. The patient is assigned a fixed dose according to their cohort. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy based on pain reduction
Change in mean pain intensity measured on an 11-point numerical rating scale (NRS)
Measured: End of the Treatment Phase (Week 7) compared to Baseline (Week -1)
Secondary outcomes (4)
Pain responders
Number and percentage of 30% and 50% pain responders
Measured: End of the Treatment Phase (Week 7) compared to Baseline (Week -1)
PGIC
Percentage of patients by answer category ('Improved', 'Not improved') of the global assessment of symptoms (PGIC, 7-point Likert scale where 0=very much better to 6=very much worse)
Measured: At the end of the Treatment Phase (Week 7)
Safety: TEAEs and TESAEs
Occurrence of treatment-emergent adverse events (TEAEs)/treatment-emergent serious adverse events (TESAEs)
Measured: Week 1 up to Week 13
Satisfaction with tolerability
Percentage of patients by answer category ("satisfied", "unsatisfied") based on the satisfaction of the patient with tolerability (5-point Likert scale, where 0=very satisfied to 4=very unsatisfied)
Measured: At the end of the Treatment Phase (Week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start28 Jun 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertanical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Johnson, Dr., Principal investigator, St Pancras Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475001
- Sponsor's protocol ID
- VER-CLBP-004
- Other IDs
- 2023-507358-34, 1008617, 2023
- Acronym
- RESPONSE
- Status last verified
- Aug 2025
- First submitted
- 12 Jun 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Randomized, Placebo-controlled, Dose Response Trial With the Full-spectrum Cannabis Extract VER-01 in Patients With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06475001
- Acronym / sponsor ID
- RESPONSE / VER-CLBP-004
- Conditions
- Chronic Non-specific Low Back Pain
- Keywords
- Chronic Pain, Neuropathic Pain, Back Pain, Back Pain, Low, Back Pain Lower Back Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- Vertanical GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 26 Jun 2024 (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.
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.
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
- 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.
| 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 patient is assigned a fixed dose according to their cohort. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered orally (b.i.d.) using a dosing syringe. The patient is assigned a fixed dose according to their cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient meets the Quebec Task Force (QTF) classification system of categories 1 to 3 of low back pain
- Male and female patients ≥ 18 years of age
- Provision of informed consent form (ICF) voluntarily signed and dated by the patient
- 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
- 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
Key exclusion criteria (23 listed)
- 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
- 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, VER-01, and/or placebo (e.g., sesame oil)
- Participation in another clinical interventional trial within the last 30 days prior Visit 1 or previous participation in a trial for VER-01
- Occupational groups with primary activity of operating machinery and driving motor vehicles
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-01Herbal 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. | Drug | VER-01 |
| PlaceboComparator without active ingredient | Drug | Placebo |
Primary outcome
Efficacy based on pain reduction
Time frame: End of the Treatment Phase (Week 7) compared to Baseline (Week -1)
Change in mean pain intensity measured on an 11-point numerical rating scale (NRS)
4 secondary outcomes
Pain responders
Time frame: End of the Treatment Phase (Week 7) compared to Baseline (Week -1)
PGIC
Time frame: At the end of the Treatment Phase (Week 7)
Safety: TEAEs and TESAEs
Time frame: Week 1 up to Week 13
Satisfaction with tolerability
Time frame: At the end of the Treatment Phase (Week 7)
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 11 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Non-specific Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
Active, not recruiting
Integrated Feldenkrais Method With and Without DNS for Chronic Low Back Pain in Females
Chronic Low Back Pain (CLBP)
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
Chronic Non-Specific Low Back Pain
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.
Martin Johnson, Dr. principal investigator
St Pancras Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VER-01 in people with Chronic Non-specific Low Back Pain, run by Vertanical GmbH at 1 site in United Kingdom.
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 23 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 11 Aug 2025. 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy based on pain reduction (time frame: End of the Treatment Phase (Week 7) compared to Baseline (Week -1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2025.