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

Ki vehet részt

• 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

Ki nem vehet részt

• 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