drugset / Trial / NCT06490445

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

NCT06490445 ↗

Phase 2 Completed 122 enrolled Syqe Medical
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary purpose of this study is to evaluate the safety and efficacy of medical cannabis aerosol containing 0.25, 0.50, 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.

Timeline

Start
2024-11-14
Primary completion
2026-05-26
Completion
2026-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Medical Cannabis Unknown 0.25 mg Inhaled
Subject Medical Cannabis Unknown 0.5 mg Inhaled
Subject Medical Cannabis Unknown 1 mg Inhaled