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

Part of paid clinical trials in Katy, Texas.

Sponsor
Vertanical GmbH
Study ID
NCT06956014
Phase
PHASE3
Status
Recruiting
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Conditions

  • Lumbosacral Radiculopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • Placebo — OTHER
    Comparator without active ingredient

Study Details

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.

Key Dates

First listed
May 2, 2025
Start date
Sep 22, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
810 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VER-01 Dose 1
  • Experimental: VER-01 Dose 2
  • Placebo Comparator: Placebo

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
R & H Clinical ResearchKatyTexas77494
Syed Ahmed
[email protected]
+1-713-904-1537

Find similar trials in Katy, TX

By research site
R & H Clinical Research· Katy, TX

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