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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06956014

Acronym

EXPAND

Enrollment

810

Registered

2025-05-02

Start date

2026-09-01

Completion date

2028-09-01

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbosacral Radiculopathy

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.

Interventions

DRUGVER-01

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

OTHERPlacebo

Comparator without active ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy based on pain reduction	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.

Contacts

CONTACTVertanical GmbH

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026