Status:
RECRUITING
A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
Lead Sponsor:
Syqe Medical
Conditions:
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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, either duloxetine or gabapentin or pregabalin as monotherapy or combination of 2.
- Not current cannabis products users, that is, participants who were previous cannabis products users for any reason but have not used cannabis products within 3 months of the screening visit, or participants who have never used cannabis products, that is, cannabis naïve participants.
- A diagnosis of DPNP (at screening).
- Confirmed diagnosis of diabetes mellitus type I or type II with stable disease.
- Glycated hemoglobin (HbA1c) less than (\<) 9% 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.
- Agree not to drive or operate heavy machinery during the study treatment period.
- 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 effective birth control methods.
Exclusion
- 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.
- Presence of skin conditions in the affected dermatome at screening or randomization that could interfere with the evaluation of the neuropathic pain condition.
- Presence of pain not associated with diabetic peripheral neuropathy (DPN) or other neuropathies that may interfere with study assessments.
- Known history of significant hypersensitivity, intolerance, adverse reaction or allergy to cannabis products, cannabinoids, or acetaminophen/paracetamol.
- Malignancies in the past 5 years prior to screening, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
- Liver disease or liver injury as indicated by abnormal liver function tests at screening.
- History or presence of impaired renal function at screening
- Presence of significant pulmonary disease at screening
- Ongoing respiratory infection at screening.
- History of acute coronary syndrome; unstable angina; congestive heart failure; cardiogenic syncope; cardiomyopathy; or symptomatic arrhythmia, or current uncontrolled blood pressure.
- 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.
- 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.
- History or presence of mental illness evidenced as defined in the protocol.
- Abnormal neurological condition or abnormal neurological examination at screening in judgment of investigator.
Key Trial Info
Start Date :
November 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 8 2025
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT06490445
Start Date
November 14 2024
End Date
November 8 2025
Last Update
April 18 2025
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Innovate Clinical Research
Waitara, New South Wales, Australia, 2077
2
Western Sydney University NICM Health Research Institute (NICM HRI)
Westmead, New South Wales, Australia, 2145
3
Westmead Hospital
Westmead, New South Wales, Australia, 2145
4
Emeritus Research
Camberwell, Victoria, Australia, 3124