Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP) (NCT06490445) is a Phase 2 interventional studying Diabetic Peripheral Neuropathic Pain, sponsored by Syqe Medical. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Diabetic Peripheral Neuropathic Pain and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 192 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Diabetic Peripheral Neuropathic Pain subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to comprehend and willing to sign the willing to sign a consent form 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Medical Cannabis

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

DRUG

Placebo

Placebo administered using Fixed-dose Syqe Inhaler.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Innovate Clinical Research

Waitara, New South Wales, Australia

Western Sydney University NICM Health Research Institute (NICM HRI)

Westmead, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Emeritus Research

Camberwell, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Rychnov nad Kneznou, Hradec Kralove

Rychnov nad Kněžnou, Hradec Kralove, Czechia

Ostrava, Ostrava City

Ostrava, Ostrava City, Czechia

Plzen, Plzen City

Pilsen, Plzen City, Czechia

Prague, Praha 12

Prague, Prague, Czechia

Heidelberg, Baden-Wuerttemberg

Heidelberg, Baden-Wurttemberg, Germany

Karlsruhe, Baden-Württemberg

Karlsruhe, Baden-Wurttemberg, Germany

Ulm, Baden-Württemberg

Ulm, Baden-Wurttemberg, Germany

Hamburg, Hamburg

Hamburg, Hamburg, Germany

Hannover, Lower Saxony

Hanover, Lower Saxony, Germany

Schwerin, Mecklenburg

Schwerin, Mecklenburg, Germany

Reinfeld, Schleswig-Holstein

Reinfeld, Schleswig-Holstein, Germany

Berlin, Berlin 4010

Berlin, State of Berlin, Germany

Berlin, Berlin

Berlin, State of Berlin, Germany

Klinische Forschung Dresden GmbH

Dresden, Germany

Klinische Forschung Schwerin GmbH

Schwerin, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06490445), the sponsor (Syqe Medical), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06490445 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06490445?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06490445?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06490445. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06490445. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.