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Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Low Back Pain (EXPAND)

V

Vertanical

Status and phase

Begins enrollment in 4 months
Phase 3

Conditions

Chronic Low Back Pain

Treatments

Drug: VER-01
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06956014
VER-CLBP-003

Details and patient eligibility

About

The aim of the trial is to prove the efficacy and safety of VER-01 corresponding to 22.5 mg or 32.5 mg THC compared to placebo in patients with chronic low back pain (CLBP) 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.

Enrollment

700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Chronic (≥ 6 months) pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). CLBP patients without a clear specific somatic cause, for which targeted therapy can have a positive effect on the course of the disease.
  • Patients with indicated opioid drug treatment where previous optimized treatments with non-opioid analgesics (including combinations) have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance

Exclusion criteria

  • Any painful comorbidity which could, in the opinion of the investigator, interfere with the low back pain intensity assessment during the trial participation
  • 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 prior to Visit 1 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

700 participants in 3 patient groups, including a placebo group

VER-01 corresponding to 22.5 mg THC
Experimental group
Treatment:
Drug: VER-01
VER-01 corresponding to 32.5 mg THC
Experimental group
Treatment:
Drug: VER-01
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

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Central trial contact

Vertanical GmbH

Data sourced from clinicaltrials.gov

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