NCT06071975

Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 558 (estimated)
• Sponsor: Apurano Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the long term efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with pain disorders due to diabetic polyneuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to diabetic polyneuropathy.

Conditions

• Pain
• Pain Syndrome
• Pain, Chronic
• Chronic Pain
• Chronic Pain Syndrome
• Diabetes
• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Peripheral Neuralgia
• Peripheral Neuropathy
• Peripheral Neuropathy With Type 2 Diabetis

Interventions

Type	Name	Description
DRUG	Adezunap (AP707)	Sublingual spray with maximum application of 16 actuations per day or a maximum daily dose of 17,6mg THC distributed over 4 daily intakes.
DRUG	Placebo	Sublingual spray with maximum application of 16 actuations per day distributed over 4 daily intakes.

Timeline

• Start date: 2023-11-02
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2023-10-10
• Last updated: 2024-01-31

Locations

1 site across 1 country: Germany