RECRUITING Phase 3 ClinicalTrials.gov

Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy

Sponsor: Vertanical GmbH • ClinicalTrials.gov ID: NCT06956014

Registry updated: 2026-10-19

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Description

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.

Interventions

VER-01 (Drug)
Standardized soft extract from Cannabis sativa DKJ127 L., cannabis flos (Cannabis flower), corresponding to 19 mg Δ9-Tetrahydrocannabinol (THC) per ml drug product
Placebo (Other)
Comparator without active ingredient

Eligibility criteria

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

Conditions

Lumbosacral Radiculopathy

Locations

AMR Mobile — Mobile, Alabama, United States
Alliance for Multispecialty Research - Tempe I — Tempe, Arizona, United States
Central Medical Research Institute — Long Beach, California, United States
Bradenton Research Center — Bradenton, Florida, United States
Green Leaf Clinical Trials — Jacksonville, Florida, United States
Floridian Research Institute LLC I — Miami, Florida, United States
Alma Clinical Research — Miami, Florida, United States
Conquest Research - Lake Nona — Orlando, Florida, United States
Alfa Medical Research - Pembroke Pines — Pembroke Pines, Florida, United States
United Medical Research — Port Orange, Florida, United States
Conquest Research - Winter Park — Winter Park, Florida, United States
Alliance for Multispecialty Research - Wichita East — Wichita, Kansas, United States
Monroe Biomedical Research - Monroe — Monroe, North Carolina, United States
Progressive Medicine of the Triad, LLC — Winston-Salem, North Carolina, United States
Velocity Clinical Research - Cleveland — Cleveland, Ohio, United States
Epic Medical Research - Chickasha — Chickasha, Oklahoma, United States
Clinitiative - Clinical Trials of South Carolina - Charleston — Charleston, South Carolina, United States
Alliance for Multispecialty Research - Knoxville — Knoxville, Tennessee, United States
R & H Clinical Research — Katy, Texas, United States
Grayline Research Center — Wichita Falls, Texas, United States
Boeson Research — Provo, Utah, United States
CenExel JBR - Salt Lake City — Salt Lake City, Utah, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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