Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Low Back Pain

Launched by VERTANICAL GMBH · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a drug called VER-01 to see if it can help people with chronic low back pain (CLBP) who haven’t found relief from other treatments. Participants in the study will receive either VER-01, which contains THC (a compound found in cannabis), or a placebo (a treatment that has no active ingredients), to compare how well it works for managing pain. The trial aims to find out if VER-01 is both effective and safe for patients aged 65 to 74 who have been dealing with back pain for at least six months and have not had enough relief from standard pain medications.

To be eligible for the trial, participants must have chronic low back pain without a clear cause and have previously tried non-opioid pain medications that didn’t help or caused side effects. However, individuals with certain health conditions, such as severe psychiatric disorders or recent heart problems, cannot participate. If you join the study, you will be monitored throughout to track how well the treatment is working and ensure your safety. This trial is not yet recruiting, but it may offer a new option for those struggling with chronic pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.