A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
Key facts
- Who runs it
- Syqe Medical
- Where
- Australia, Czechia, Germany, Israel, and Poland38 sites in 5 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 122 people enrolled
- Started
- 14 Nov 2024
- Ended
- 24 Jun 2026
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Medical Cannabis
- Placebo
- Record updated
- 29 June 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- Able to comprehend and willing to sign the informed consent form (ICF), and willing to abide by the study restrictions
- Males and females aged between 18 (included) and 75 (included) years
- Agree to use only medical cannabis provided by study team until the end of study (EOS) and not to use any other cannabis or cannabis-containing products
- Agree not to participate in other interventional clinical studies during participation in this study
- Treated with standard of care for DPNP, defined as either duloxetine, gabapentin or pregabalin as monotherapy or a combination of 2, or participants who discontinued the use of standard of care, or amitriptyline used for the management of pain related to DPNP, at least 3 months prior to screening
- Confirmed diagnosis of diabetes mellitus type I or type II with stable disease
- Glycated hemoglobin (HbA1c) less than or equal to (<=) 10% at screening
- Body mass index between 18 and 40 kilograms per square meter (kg/m\^2), inclusive
- Have at least 5 out of 7 records of daily average pain intensity recordings in the 7 days prior to randomization
- Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the administration of study treatment on Day 1or be of non-child-bearing potential as defined in the protocol
- Participants of reproductive potential who are sexually active must use highly effective birth control methods
Who cannot take part
- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol at screening or randomization, ability to complete the study, or study assessments
- Malignancies in the past 5 years prior to screening, except for cutaneous basal cell or squamous cell carcinoma resolved by excision
- Concomitant clinically significant cardiac arrhythmias, examples, sustained ventricular tachycardia, and second or third degree atrioventricular block without a pacemaker, or any other relevant cardiac disease in the judgment of the investigator
- Presence of skin conditions in the affected dermatome at screening or randomization that could interfere with the evaluation of the neuropathic pain condition
- Known history of significant hypersensitivity, intolerance, adverse reaction or allergy to cannabis products, cannabinoids, or acetaminophen/paracetamol
- Liver disease or liver injury as indicated by abnormal liver function tests at screening
- Presence of significant pulmonary disease at screening
- Ongoing respiratory infection
- History of acute coronary syndrome in the last 12 months; unstable angina; congestive heart failure; cardiogenic syncope; cardiomyopathy; or symptomatic arrhythmia, or current uncontrolled blood pressure
- History or presence of mental illness evidenced as defined in the protocol
- Abnormal neurological condition or abnormal neurological examination other than related to DPN as judged by the investigator at screening that impacts the assessment of study endpoints
- History of clinically significant electrocardiograms (ECG) abnormalities, or any of the following ECG abnormalities at screening or baseline:; PR greater than (>) 200 milliseconds (msec); QRS complex >120 msec; Fridericia QT correction formula (QTcF) greater than (>) 450 msec; History of familial long QT syndrome or known family history of ventricular arrythmia; Acute ischemic changes
- Presence of pain not associated with diabetic peripheral neuropathy (DPN) or other neuropathies that may interfere with study assessments
- History or presence of impaired renal function at screening
This trial has no sites in United States.
It has sites in 5 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- PlaceboPlacebo, for comparison
Participants will receive placebo, inhaled TID via the Fixed-dose Syqe Inhaler.
- 0.25 mg THCTreatment being tested
Participants will inhale medical cannabis aerosol containing 0.25 mg THC via the Fixed-dose Syqe Inhaler three times a day.
Treatment: Medical Cannabis
- 0.5 mg THCTreatment being tested
Participants will inhale medical cannabis aerosol containing 0.5 mg THC via the Fixed-dose Syqe Inhaler three times a day.
Treatment: Medical Cannabis
- 1.0 mg THCTreatment being tested
Participants will inhale medical cannabis aerosol containing 1.0 mg THC via the Fixed-dose Syqe Inhaler three times a day.
Treatment: Medical Cannabis
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Record updated
- 29 June 2026