RCT of Medical Cannabis Aerosol for DPNP Treatment
- Conditions
- Diabetic Peripheral Neuropathic PainMedDRA version: 21.1Level: LLTClassification code: 10067547Term: Diabetic peripheral neuropathic pain Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-508932-68-00
- Lead Sponsor
- Syqe Medical Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 192
Able to comprehend and willing to sign the informed consent form (ICF), and willing to abide by the study restrictions., Body mass index between 18 and 40 kg/m2, 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 patients must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to the administration of study treatment on Day 1; alternatively, female patients of non-child-bearing potential must fulfil 1 of the following criteria at screening: • Post-menopausal defined as aged more than 50 years old and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments. • Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and having luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range as per the central laboratory assessments. • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation., Patients of reproductive potential and sexually active must use highly effective birth control methods, defined as: • For females: hormonal contraceptives, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, abstinence for duration of the trial (if it is patient lifestyle choice). • For males: vasectomy, or abstinence for duration of the trial (if it is patient lifestyle choice)., Males and females aged =18 to =75 years at screening., Agree to use only MC provided by study team until the EOS period and not to use any other cannabis or cannabis-containing products including, but not limited to products that are smoked, inhaled, ingested, or topically administered, or over-the-counter CBD products., Agree not to participate in other interventional clinical studies during participation in this study., Treated with standard of care for DPNP, either duloxetine, gabapentin or pregabalin as monotherapy or a combination of 2. The standard-of-care treatment and dosage must have been stable for at least 30 days prior to screening and without intention to change during the study. Patients who receive non-pharmacological, non-invasive pain therapy eg, behavioral, or cognitive therapy etc, are allowed to enroll, provided there was no change reported to these therapies within 3 months before screening and no changes planned during the study., Not current cannabis products users, ie, patients who were previous cannabis products users for any reason but have not used cannabis within 3 months of the screening visit, or patients who have never used cannabis, ie, cannabis naïve patients., A diagnosis of DPNP (at screening), including: • Daily symmetrical foot pain secondary to peripheral neuropathy present for at least 6 months and classified =3 as diagnosed through use of the Michigan Neuropathy Screening Instrument Part B. • Definite or probable neuropathic pain for a duration of >3 months with a mean average pain intensity score of =4 and =9 (Numeric Rating Scale [NRS]; the absolute range of scores [maximum score - minimum score] not exceeding 4) assessed during the last 7 days prior to randomization., Confirmed diagnosis of diabetes mellitus type I or type II with stable disease
Evidence of significant uncontrolled concomitant disease that, in the judgment of the investigator, could affect compliance with the protocol at screening or randomization, ability to complete the study, and study assessments., History of drug or alcohol abuse within the 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening (including ?9-THC and opiates)., History of seizure disorders (excluding childhood febrile convulsions) or epilepsy., Presence of skin conditions in the affected dermatome at screening or randomization that, in the judgment of the investigator, could interfere with the evaluation of the neuropathic pain condition., Inadequate hematological function, defined as neutrophil count <1.0 × 10^9/L and/or platelet count <50 × 10^9/L at screening., History of surgical or other nonpharmacological treatments (eg, neurolytic or neurosurgical therapy) that, in the opinion of the investigator, may influence the result of the study, or the patient's ability to participate in the study., Prior use of the Syqe Inhaler for the administration of cannabis sativa L ‘Afina’ aerosol., Plans to change current medications or any other intervention intended to treat or relieve DPNP signs or symptoms from screening to EOS., Use of prohibited medications., Any factor or condition likely to affect compliance, study intervention, visit plan or assessments as judged by the investigator., Presence of pain not associated with diabetic peripheral neuropathy or other neuropathies that may interfere with study assessments., History of acute coronary syndrome; unstable angina; congestive heart failure; cardiogenic syncope; cardiomyopathy; or symptomatic arrhythmia, or current uncontrolled blood pressure., 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 including elevated alanine aminotransferase, aspartate aminotransferase, serum glutamic-pyruvic transaminase, gamma-glutamyl transpeptidase, alkaline phosphatase, or serum bilirubin exceeding 2 × upper limit of normal., History or presence of impaired renal function at screening • As indicated by clinically significantly abnormal creatinine or blood urea nitrogen and/or urea values, or abnormal urinary constituents (eg, albuminuria). • Significant renal insufficiency, indicated by an estimated glomerular filtration rate using the modification of diet in renal disease equation of < 60 mL/min ÷ 1.73 m2 at screening (as calculated by the central laboratory). • Evidence of urinary obstruction or difficulty in voiding at screening., Presence of significant pulmonary disease at screening • Abnormal respiratory assessment including forced expiratory volume in the first second (FEV1) <80% predicted value and/or FEV1/forced vital capacity <70% • History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease treated or not treated). • History of diagnosis of any pulmonary disease that in the judgment of the investigator is likely to be exacerbated by use of the Syqe Inhaler., Ongoing respiratory tract infection at screening., Female patients who are breast feeding or pregnant (
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method