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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VER-01 Dose 1 | Experimental |
| |
| VER-01 Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vertanical GmbH | Contact | +49 (0)89 787 97 90 - 0202 | regulatory@vertanical.com |
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| Placebo | Other | Comparator without active ingredient |
|