Recruiting
Phase 3

VER-01

Sponsor:

Vertanical GmbH

Code:

NCT06956014

Conditions

Lumbosacral Radiculopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VER-01

Placebo

Study Details

Brief 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.

Conditions

Lumbosacral Radiculopathy

Study ID

NCT06956014

Start date

Sep 22, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

810 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VER-01 Dose 1

experimental: VER-01 Dose 2

placebo comparator: Placebo

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

Primary outcome measure

  • Efficacy based on pain reduction [ Time Frame: From Baseline to Treatment Week 12 ]

Central Contacts and Locations

Locations

AMR Mobile

Recruiting

Mobile, Alabama, United States, 36608

Contacts

Alliance for Multispecialty Research - Tempe I

Recruiting

Tempe, Arizona, United States, 85281

Contacts

Central Medical Research Institute

Recruiting

Long Beach, California, United States, 90802

Contacts

Tekton Research - Longmont

Recruiting

Longmont, Colorado, United States, 80501

Contacts

Bradenton Research Center

Recruiting

Bradenton, Florida, United States, 34205

Contacts

AGA Clinical Trials

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Green Leaf Clinical Trials

Recruiting

Jacksonville, Florida, United States, 32258

Contacts

K2 Medical Research - Maitland II

Recruiting

Maitland, Florida, United States, 32751

Contacts

Floridian Research Institute LLC I

Recruiting

Miami, Florida, United States, 33179

Contacts

Alma Clinical Research

Recruiting

Miami, Florida, United States, 33184

Contacts

Conquest Research - Lake Nona

Recruiting

Orlando, Florida, United States, 32832

Contacts

Alfa Medical Research - Pembroke Pines

Recruiting

Pembroke Pines, Florida, United States, 33029

Contacts

United Medical Research

Recruiting

Port Orange, Florida, United States, 32738

Contacts

Conquest Research - Winter Park

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Alliance for Multispecialty Research - Wichita East

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Elixia Clinical Research Collaborative

Recruiting

Springfield, Massachusetts, United States, 01103

Contacts

Monroe Biomedical Research - Monroe

Recruiting

Monroe, North Carolina, United States, 28112

Contacts

Progressive Medicine of the Triad, LLC

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Velocity Clinical Research - Cleveland

Recruiting

Cleveland, Ohio, United States, 44122

Contacts

Epic Medical Research - Chickasha

Recruiting

Chickasha, Oklahoma, United States, 73018

Contacts

Velocity Clinical Research - Medford

Recruiting

Medford, Oregon, United States, 97504

Contacts

Clinitiative - Clinical Trials of South Carolina - Charleston

Recruiting

Charleston, South Carolina, United States, 29406

Contacts

Alliance for Multispecialty Research - Knoxville

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Central Texas Clinical Research, LLC

Recruiting

Austin, Texas, United States, 78705

Contacts

DFW Clinical Trials

Recruiting

Carrollton, Texas, United States, 75010

Contacts

Innovare Research Group I

Recruiting

Friendswood, Texas, United States, 77456

Contacts

Synergy Groups Medical - Southeast Houston

Recruiting

Houston, Texas, United States, 77036

Contacts

R & H Clinical Research

Recruiting

Katy, Texas, United States, 77494

Contacts

Epic Clinical Research - Lewisville

Recruiting

Lewisville, Texas, United States, 75057

Contacts

Grayline Research Center

Recruiting

Wichita Falls, Texas, United States, 76309

Contacts

Boeson Research

Recruiting

Provo, Utah, United States, 84604

Contacts

CenExel JBR - Salt Lake City

Recruiting

Salt Lake City, Utah, United States, 84107

Contacts

More Information

Sponsor

Vertanical GmbH

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Vertanical GmbH on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.