INTERVENTIONALCOMPLETEDNCT06490445

A Double-blind, Randomized, Placebo-controlled, 4-arm Parallel-group, Multiple-Dose Study to Assess Efficacy and Safety of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain

The primary purpose of this study is to evaluate the safety and efficacy of medical cannabis aerosol containing 0.25, 0.50, 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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-06-29

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 122 (ACTUAL)
Start date: 2024-11-14
Sponsor: Syqe Medical
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 38
Results record: Not present in registry snapshot

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 of Δ9-THC added on to standard of care for treatment of DPNP. The target sample size is 192 eligible participants worldwide, randomized from up to approximately 51 recruiting sites in up to approximately 8 countries. The study consists of 1) a screening period of up to 14 days; 2) a 15-week, parallel-group, randomized, double-blind treatment period, including a 3-week up-titration period and a 12-week maintenance period; and 3) a post-treatment, safety follow-up period of 4 weeks.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Medical Cannabis

Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.

DRUG

Placebo

Placebo administered using Fixed-dose Syqe Inhaler.

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Not accepted

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, 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. 6. Confirmed diagnosis of diabetes mellitus type I or type II with stable disease. 7. Glycated hemoglobin (HbA1c) less than or equal to (\<=) 10% at screening. 8. Body mass index between 18 and 40 kilograms per square meter (kg/m\^2), inclusive. 9. Have at least 5 out of 7 records of daily average pain intensity recordings in the 7 days prior to randomization. 10. 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. 11. Participants of reproductive potential who are sexually active must use highly 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. 10. 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. 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:

primary outcomes

primary measures

Change From Baseline in Weekly-mean 24-hour Average Pain Score on the Numeric Rating Scale (NRS) at Week 15

Time frame: Baseline and 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.

secondary outcomes