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Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
Sponsor: Vertanical GmbH
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
810
Start Date
2026-09-22
Completion Date
2028-09
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
VER-01
Standardized soft extract from Cannabis sativa DKJ127 L., cannabis flos (Cannabis flower), corresponding to 19 mg Δ9-Tetrahydrocannabinol (THC) per ml drug product
Placebo
Comparator without active ingredient
Locations (32)
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
Tekton Research - Longmont
Longmont, Colorado, United States
Bradenton Research Center
Bradenton, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Green Leaf Clinical Trials
Jacksonville, Florida, United States
K2 Medical Research - Maitland II
Maitland, 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
Elixia Clinical Research Collaborative
Springfield, Massachusetts, 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
Velocity Clinical Research - Medford
Medford, Oregon, United States
Clinitiative - Clinical Trials of South Carolina - Charleston
Charleston, South Carolina, United States
Alliance for Multispecialty Research - Knoxville
Knoxville, Tennessee, United States
Central Texas Clinical Research, LLC
Austin, Texas, United States
DFW Clinical Trials
Carrollton, Texas, United States
Innovare Research Group I
Friendswood, Texas, United States
Synergy Groups Medical - Southeast Houston
Houston, Texas, United States
R & H Clinical Research
Katy, Texas, United States
Epic Clinical Research - Lewisville
Lewisville, 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