Status:
NOT_YET_RECRUITING
Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Low Back Pain
Lead Sponsor:
Vertanical GmbH
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of the trial is to prove the efficacy and safety of VER-01 corresponding to 22.5 mg or 32.5 mg THC compared to placebo in patients with chronic low back pain (CLBP) for whom drug treatment is ...
Eligibility Criteria
Inclusion
- Chronic (≥ 6 months) pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). CLBP patients without a clear specific somatic cause, for which targeted therapy can have a positive effect on the course of the disease.
- 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
Exclusion
- Any painful comorbidity which could, in the opinion of the investigator, interfere with the low back pain intensity assessment during the trial participation
- Pregnant or breastfeeding female patients
- Known history of previous or current severe psychiatric disorder as per DSM-5 (e.g., schizophrenia, bipolar disorder, severe anxiety disorder, psychotic disorder, post-traumatic stress disorder), or currently taking antipsychotic medication.
- Cardiovascular event or clinically significant cardiac dysfunction (e.g., congestive heart failure, myocardial ischemia, arrhythmias, poorly controlled high blood pressure, congenital long QT syndrome) within 12 months prior to Visit 1 or a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06956014
Start Date
March 1 2026
End Date
September 1 2027
Last Update
July 14 2025
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