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

Last updated: June 22, 2026
Sponsor: Vertanical GmbH
Overall Status: Active - Not Recruiting

Phase

3

Condition

Radiculopathy

Chronic Pain

Treatment

Placebo

VER-01

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: Placebo
Phase: 3
Study Start date:
September 01, 2026
Estimated Completion Date:
September 30, 2028