Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
RecruitingPhase 3NCT06956014
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The aim of the trial is to prove the efficacy and safety of VER-01 compared to placebo in patients with chronic painful lumbosacral radiculopathy (PLSR) 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 details
- Official title
- Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of the Full-spectrum Cannabis Extract VER-01 in Participants With Chronic Painful Lumbosacral Radiculopathy
- Conditions
- Lumbosacral Radiculopathy
- Interventions
- Sponsor
- Vertanical GmbH
- Start date
- 2026-09-22
- Primary completion
- 2028-09
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 22
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Participants ≥ 18 years of age, all sexes * Participant voluntarily provided written informed consent * Participant is willing and able to comply with scheduled visits, treatment plan, eDiary, and other trial-related procedures throughout trial participation Exclusion Criteria: * 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 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06956014