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NCT06956014PHASE3Recruiting

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

Vertanical GmbH

Start Date

9/22/2026

Completion Date

9/1/2028

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

Age Range: 18 years to No maximum

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

Interventions

DRUG

VER-01

OTHER

Placebo

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Conditions

Lumbosacral Radiculopathy

Locations

R & H Clinical Research

Katy, Texas 77494

United States