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

NCT06956014 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: VER-CLBP-003
• Study Type: interventional
• Target: 810
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Efficacy based on pain reduction

  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.

  From Baseline to Treatment Week 12

Study Arms (3)

VER-01 Dose 1

EXPERIMENTAL

Drug: VER-01

VER-01 Dose 2

EXPERIMENTAL

Drug: VER-01

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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

VER-01 Dose 1; VER-01 Dose 2

Placebo OTHER

Comparator without active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertanical GmbH: lead

Central Study Contacts

Vertanical GmbH

CONTACT

+49 (0)89 787 97 90 - 0202; regulatory@vertanical.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share