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

Last updated: October 20, 2026
Sponsor: Vertanical GmbH
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Pain

Radiculopathy

Treatment

VER-01

Placebo

Clinical Study ID

NCT06956014
VER-CLBP-003
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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., congestiveheart failure, myocardial ischemia, arrhythmias, poorly controlled high bloodpressure, 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 clinicallysignificant arrhythmia or myocardial infarction

Study Design

Total Participants: 810
Treatment Group(s): 2
Primary Treatment: VER-01
Phase: 3
Study Start date:
September 22, 2026
Estimated Completion Date:
September 30, 2028

Connect with a study center

  • AMR Mobile

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Tempe I

    Tempe, Arizona 85281
    United States

    Active - Recruiting

  • Central Medical Research Institute

    Long Beach, California 90802
    United States

    Active - Recruiting

  • Bradenton Research Center

    Bradenton, Florida 34205
    United States

    Active - Recruiting

  • Green Leaf Clinical Trials

    Jacksonville, Florida 32258
    United States

    Active - Recruiting

  • Alma Clinical Research

    Miami, Florida 33184
    United States

    Active - Recruiting

  • Floridian Research Institute LLC I

    Miami, Florida 33179
    United States

    Active - Recruiting

  • Conquest Research - Lake Nona

    Orlando, Florida 32832
    United States

    Active - Recruiting

  • Alfa Medical Research - Pembroke Pines

    Pembroke Pines, Florida 33029
    United States

    Active - Recruiting

  • United Medical Research

    Port Orange, Florida 32738
    United States

    Active - Recruiting

  • Conquest Research - Winter Park

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Wichita East

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Monroe Biomedical Research - Monroe

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • Progressive Medicine of the Triad, LLC

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Velocity Clinical Research - Cleveland

    Cleveland, Ohio 44122
    United States

    Active - Recruiting

  • Epic Medical Research - Chickasha

    Chickasha, Oklahoma 73018
    United States

    Active - Recruiting

  • Clinitiative - Clinical Trials of South Carolina - Charleston

    Charleston, South Carolina 29406
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research - Knoxville

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • R & H Clinical Research

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Epic Clinical Research - Lewisville

    Lewisville, Texas 75057
    United States

    Active - Recruiting

  • Grayline Research Center

    Wichita Falls, Texas 76309
    United States

    Active - Recruiting

  • Boeson Research

    Provo, Utah 84604
    United States

    Active - Recruiting

  • CenExel JBR - Salt Lake City

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

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