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Adezunap in Chronic Pain Due to Diabetic Polyneuropathy
NCT06072573Phase 3
Key facts
- Status
- Recruiting
- Start
- Nov 2023
- Primary completion
- Sep 2024
- Countries
- 1
- Sponsor
- Apurano Pharmaceuticals GmbH
- Modality
- Small Molecules, Lipid-based Nanoparticles
- Drugs
- adezunap
- Conditions
- diabetic polyneuropathy (DPN)
01
Overview
Phase 3, randomised, double-blind trial in diabetic polyneuropathy (DPN) comparing Adezunap with Placebo (2 arms). Primary endpoint: Numeric Rating Scale at 14 weeks. Started Nov 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Adezunap
Adezunap sublingual spray + Standard of Care
Placebo
Placebo sublingual spray + Standard of Care
03
Who it enrols
Adult patients with chronic pain due to diabetic polyneuropathy (pain score > 5) on stable standard care, excluding those with severe cardiovascular, liver, or kidney disease, or recent cannabis use.
04
Endpoints
Primary
Numeric Rating Scale
Secondary
Neuropathic Pain Symptom Inventory
Responder Analysis
Standard Chronic Pain Therapy Change
Depression Anxiety Stress Scales Short Form
Patient Global Impression of Change
Veterans RAND 12 Item Health Survey
Regensburg Insomnia Scale
Brief Pain Inventory - Short Form
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