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

Launched by SYQE MEDICAL · Jun 30, 2024

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ClinConnect Summary

This clinical trial is studying the effects of a medical cannabis aerosol, delivered through a special inhaler, on diabetic peripheral neuropathic pain (DPNP), which is a type of pain caused by nerve damage from diabetes. Researchers want to see if different doses of delta-9-tetrahydrocannabinol (THC), the active ingredient in cannabis, can help reduce pain levels when used alongside standard treatments like duloxetine or gabapentin. The trial is currently recruiting participants aged 18 to 75 who have DPNP and have been stable on their diabetes treatments. Participants must be willing to use only the study's cannabis product and not have used any cannabis products in the three months before joining the study.

If eligible, participants will receive either the medical cannabis aerosol or a placebo (a non-active treatment) three times a day for 15 weeks. Those in the trial will need to track their daily pain levels and will be carefully monitored throughout the study. It's important to know that participants cannot drive or operate heavy machinery during the treatment period and must meet specific health criteria to ensure their safety. This study aims to provide insights into how well this inhaled cannabis treatment can help with pain management in people suffering from diabetic nerve pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to comprehend and willing to sign the informed consent form (ICF), and willing to abide by the study restrictions.
• • 2. Males and females aged between 18 (included) and 75 (included) years.
• • 3. 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.
• • 4. Agree not to participate in other interventional clinical studies during participation in this study.
• • 5. Treated with standard of care for DPNP, either duloxetine or gabapentin or pregabalin as monotherapy or combination of 2.
• • 6. 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.
• • 7. A diagnosis of DPNP (at screening).
• • 8. Confirmed diagnosis of diabetes mellitus type I or type II with stable disease.
• • 9. Glycated hemoglobin (HbA1c) less than (\<) 9% at screening.
• • 10. Body mass index between 18 and 40 kilograms per square meter (kg/m\^2), inclusive.
• • 11. Have at least 5 out of 7 records of daily average pain intensity recordings in the 7 days prior to randomization.
• • 12. Agree not to drive or operate heavy machinery during the study treatment period.
• • 13. 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.
• • 14. Participants of reproductive potential who are sexually active must use effective birth control methods.
• Exclusion Criteria:
• • 1. 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.
• • 2. Presence of skin conditions in the affected dermatome at screening or randomization that could interfere with the evaluation of the neuropathic pain condition.
• • 3. Presence of pain not associated with diabetic peripheral neuropathy (DPN) or other neuropathies that may interfere with study assessments.
• • 4. Known history of significant hypersensitivity, intolerance, adverse reaction or allergy to cannabis products, cannabinoids, or acetaminophen/paracetamol.
• • 5. Malignancies in the past 5 years prior to screening, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
• • 6. Liver disease or liver injury as indicated by abnormal liver function tests at screening.
• • 7. History or presence of impaired renal function at screening
• • 8. Presence of significant pulmonary disease at screening
• • 9. Ongoing respiratory infection at screening.
• • 10. History of acute coronary syndrome; unstable angina; congestive heart failure; cardiogenic syncope; cardiomyopathy; or symptomatic arrhythmia, or current uncontrolled blood pressure.
• • 11. 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.
• 12. 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.
• • 13. History or presence of mental illness evidenced as defined in the protocol.
• • 14. Abnormal neurological condition or abnormal neurological examination at screening in judgment of investigator.