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NCT Number: NCT06956014

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

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.

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Key information

Conditions

Lumbosacral Radiculopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VER-01

Drug

Standardized soft extract from Cannabis sativa DKJ127 L., cannabis flos (Cannabis flower), corresponding to 19 mg Δ9-Tetrahydrocannabinol (THC) per ml drug product

Placebo

Other

Comparator without active ingredient

Primary outcomes

  1. Efficacy based on pain reduction

    Time frame: From Baseline to Treatment Week 12

    The primary endpoint is the absolute change in mean leg pain intensity in the index leg measured on an 11-point numerical rating scale (NRS) at Treatment Week 12 compared to Baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Vertanical GmbH

CONTACT

[email protected]

+49 (0)89 787 97 90 - 0202

Sponsors and collaborators

Lead sponsor

Vertanical GmbH

Industry

Registry information

Official study 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

Acronym: EXPAND

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 2, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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