Recruiting
Phase 3

VER-01

Sponsor:

Vertanical GmbH

Code:

NCT06956014

Conditions

Lumbosacral Radiculopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VER-01

Placebo

Study Details

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

Study ID

NCT06956014

Start date

Sep 22, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

810 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VER-01 Dose 1

experimental: VER-01 Dose 2

placebo comparator: Placebo

Interventions

VER-01

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

Placebo

Comparator without active ingredient

Primary outcome measure

  • Efficacy based on pain reduction [ Time Frame: From Baseline to Treatment Week 12 ]

Central Contacts and Locations

Central contacts

Vertanical GmbH

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

Locations

R & H Clinical Research

Recruiting

Katy, Texas, United States, 77494

Contacts

Syed Ahmed

+1-713-904-1537info@rhclinicalresearch.com

More Information

Sponsor

Vertanical GmbH

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Vertanical GmbH on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.