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

NCT06490445 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Diabetic Peripheral Neuropathic Pain

Interventions

DRUG

Medical Cannabis

Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.

DRUG

Placebo

Placebo administered using Fixed-dose Syqe Inhaler.

Sponsors & Collaborators

  • Syqe Medical

    lead INDUSTRY

Principal Investigators

  • Edith Dekel · Syqe Medical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-14
Primary Completion
2026-06-20
Completion
2026-07-20

Countries

  • Australia
  • Czechia
  • Germany
  • Israel
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06490445 on ClinicalTrials.gov