NCT06490445

A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)

A Double-blind, Randomized, Placebo-controlled, 4-arm Parallel-group, Multiple-Dose Study to Assess Efficacy and Safety of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Syqe Medical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the efficacy of medical cannabis aerosol containing 0.25, 0.5, 1.0 milligrams (mg) delta (Δ)9-tetrahydrocannabinol (THC) inhaled three times a day (TID) compared to placebo via the Fixed-dose Syqe Inhaler on pain intensity at Week 15.

Detailed description

This study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of medical cannabis aerosol inhaled via the Syqe Inhaler at nominal doses of 0 (placebo), 0.25, 0.5, and 1.0 mg TID of Δ9-THC added on to standard of care for treatment of DPNP. The target sample size is 192 eligible participants worldwide, randomized from up to approximately 51 recruiting sites in up to approximately 8 countries. The study consists of 1) a screening period of up to 14 days; 2) a 15-week, parallel-group, randomized, double-blind treatment period, including a 3-week up-titration period and a 12-week maintenance period; and 3) a post-treatment, safety follow-up period of 4 weeks.

Conditions

• Diabetic Peripheral Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Medical Cannabis	Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.
DRUG	Placebo	Placebo administered using Fixed-dose Syqe Inhaler.

Timeline

• Start date: 2024-11-14
• Primary completion: 2025-10-11
• Completion: 2025-11-08
• First posted: 2024-07-08
• Last updated: 2025-04-18

Locations

38 sites across 5 countries: Australia, Czechia, Germany, Israel, Poland