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Cannabidiol for Painful Diabetic Peripheral Neuropathy of the Feet
NCT04679545Phase 2
Key facts
- Status
- Unknown
- Start
- Dec 2020
- Primary completion
- Mar 2021
- Countries
- 1
- Sponsor
- Pure Green Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- cannabidiol
- Conditions
- diabetic peripheral neuropathy (DPN)
01
Overview
Phase 2, randomised, double-blind trial in diabetic peripheral neuropathy (DPN) comparing CBD with Placebo (2 arms). Primary endpoint: Incidence of treatment-related adverse events at 4 weeks. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
CBD
20 mg CBD sublingual tablets TID
Placebo
Placebo sublingual tablets TID
03
Who it enrols
Adult patients aged 21 or older with a diagnosis of painful diabetic peripheral neuropathy of the feet and a mean pain score >= 5. Patients must washout current pain medications (gabapentin, pregabalin, duloxetine, opioids, NSAIDs) and abstain from cannabis products.
04
Endpoints
Primary
Incidence of treatment-related adverse events
Secondary
Pain as assessed by Numerical Pain Rating Scale
Anxiety as assessed by the Zung Self-Rating Anxiety Scale
Sleep Quality as assessed by Pittsburgh Sleep Quality Index
Subject's Response to Treatment as assessed by Patient's Global Impression of Change
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