A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
NCT Number: NCT06490445
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Interventions: DRUG: Medical Cannabis|DRUG: Placebo
Sponsor: Syqe Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 192
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-18
Completion Date: 2025-11-08
Locations: Clinical Republican Hospital \"Timofei Mosneaga\", ARENSIA E.M., Chisinau, 2025, Moldova, Republic of

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) compared to placebo via the Fixed-dose Syqe Inhaler on pain intensity at Week 15.

Primary Outcome Measures: Change From Baseline in Weekly-mean 24-hour Average Pain Score on the Numeric Rating Scale (NRS) at Week 15, The NRS is an 11-point scale with scores ranging from 0 (no pain) to 10 (worst pain imaginable) for measuring participant self-reporting of pain intensity. A reduction in the score over time represents an improvement., Baseline and at Week 15
Secondary Outcome Measures: Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI), The NPSI is a 12-items patient reported outcome (PRO) measure that contains 10 descriptors representing 5 dimensions of pain (burning pain, deep/pressing pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia), and 2 temporal items designed to assess pain duration and the number of pain paroxysms. Total score range for NPSI is 0-100, higher scores indicate more severity., Baseline up to Week 19|Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Scale, The BPI-SF allows participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function using a 0 to 10 NRS. A higher score indicates more severity or more interference., Baseline up to Week 19|Change From Baseline in Weekly-mean 24-hour Average, Worst and Least Pain Score on the NRS, The NRS is an 11-point scale with scores ranging from 0 (no pain) to 10 (worst pain imaginable) for measuring participant self-reporting of pain intensity. A reduction in the score over time represents an improvement., Baseline up to Week 19|Proportion of Participants Achieving at least 30 Percent (%) and 50% Reduction From Baseline in the Weekly-mean 24-hour Average Pain Score on the NRS, The NRS is an 11-point scale with scores ranging from 0 (no pain) to 10 (worst pain imaginable) for measuring participant self-reporting of pain intensity. A reduction in the score over time represents an improvement., Baseline up to Week 19|Proportion of Participants with Treatment-emergent Adverse Events (TEAEs) and Their Severity, Baseline up to Week 19|Proportion of Participants With Adverse Events (AEs) Leading to Study Treatment Discontinuation and Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs)., Baseline up to Week 19|Assessment of Diabetic Neuropathy using the Michigan Neuropathy Screening Instrument (MNSI) - Part B, The MNSI Part B consists of visual inspection of the feet and assessment of ankle reflexes, vibration sense, and monofilament testing. The measure is a score between 0 (normal) and 10 (most severe)., Baseline up to Week 19|Assessment of Suicidal Ideation and Behavior using the Columbia Suicide Severity Rating Scale (C-SSRS), The C-SSRS is a semi-structured interview to assess the presence and severity of suicidal ideation and behavior., Baseline up to Week 19|Assessment of Withdrawal Symptoms After Termination of Study Treatment using the Study Medication Withdrawal Questionnaire Version 2 (SMWQ V2), The SMWQ V2 is a 10-item patient-reported measure, where responses related to withdrawal symptoms are rated on 5-level Lickert scales between 0 (not at all) and 4 (very much)., Baseline up to Week 19|Number of Participants With Clinically Significant Abnormal Lung Function Measured using Spirometry, Spirometry is a test that measures how much air can be breathed out in one forced breath. It is used to measure acute effects of study treatment on lung function. Spirometry testing will include measurement of forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and FEV1/FVC., Baseline up to Week 19|Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG), An ECG is a test that records the electrical activity of the heart. It is used to measure acute effects of study treatment on heart function., Baseline up to Week 19|Number of Participants With Clinically Significant Abnormality in Blood and Urine Parameters, A variety of laboratory tests will be used to identify any clinically significant abnormalities., Baseline up to Week 19|Pharmacokinetics - Ctrough, Pre-dose plasma concentration (Ctrough) of Δ9-THC, cannabidiol, cannabinol, 11-OH-THC, and 11-COOH-THC., At selected visits from baseline up to Week 16|Pharmacokinetics - Cmax,ss, Maximum observed plasma steady state concentration (Cmax,ss) for Δ9-THC, cannabidiol, cannabinol, 11-OH-THC, and 11-COOH-THC., At selected visits from baseline up to Week 16|Pharmacokinetics - Tmax,ss, Time to reach maximum observed plasma steady state concentration (Tmax,ss) for Δ9-THC, cannabidiol, cannabinol, 11-OH-THC, and 11-COOH-THC., At selected visits from baseline up to Week 16|Pharmacokinetics - AUC, Area under the concentration-time curve (AUC) for Δ9-THC, cannabidiol, cannabinol, 11-OH-THC, and 11-COOH-THC., At selected visits from baseline up to Week 16|Proportion of Participants who Need Rescue Medication for the Treatment of DPNP, Baseline up to Week 19|Frequency of Rescue Medication Taken for the Treatment of DPNP, Baseline up to Week 19|Amount of Rescue Medication Taken for the Treatment of DPNP, Baseline up to Week 19|Time to First Intake of Rescue Medication Taken for the Treatment of DPNP, Baseline up to Week 19|Change From Baseline in Weekly-mean 24-hour Sleep Score Using the Daily Sleep Interference Scale (DSIS), The DSIS diary consists of an 11-point Likert scale with which participants assess how pain has interfered with their sleep during the past 24 hours. On this scale a 0 indicates "pain does not interfere with sleep" and 10 indicates "pain completely interferes with sleep." A higher score indicates more inference of pain with sleep., Baseline up to Week 19|Change From Baseline in Sleep Score Using the Pain and Sleep Questionnaire-3 (PSQ-3), The PSQ-3, also called Chronic Pain Sleep Inventory©, is a patient-reported 3-item index to assess the impact of chronic pain on sleep over the past 7 days. Each item is reported on a visual analog scale (VAS) between "never" and "always". The score ranges from 0 to 100., Baseline up to Week 19|Change From Baseline in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Profile Total Score, PROMIS-29 Profile v2.1 is a set of person-centered measures that evaluates and monitors physical, mental, and social health. PROMIS-29 Profile v2.1 consists of 7 domains with a total of 29 questions answered on Lickert scales., Baseline up to Week 19