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

NCT06490445 | Active Not Recruiting Phase 2

• 2 other identifiers: Syqe-0042023-508932-68-00
• Study Type: interventional
• Target: 122
• Locations: 5 countries
• Sites: 38

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

Diabetes; Neuropathy; Painful diabetic neuropathy; Chronic Neuropathic Pain; DPNP; Cannabis; Medical cannabis; Inhaled; Aerosol; Placebo; Randomized; Double-blind

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI)

  Baseline up to Week 19

• Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Scale

  Baseline up to Week 19

• Change From Baseline in Weekly-mean 24-hour Average, Worst and Least Pain Score on the NRS

  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

  Baseline up to Week 19

• Proportion of Participants with Treatment-emergent Adverse Events (TEAEs) and Their Severity

  Baseline up to Week 19

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo, inhaled TID via the Fixed-dose Syqe Inhaler.

Drug: Placebo

0.25 mg THC

EXPERIMENTAL

Participants will inhale medical cannabis aerosol containing 0.25 mg THC via the Fixed-dose Syqe Inhaler three times a day.

Drug: Medical Cannabis

0.5 mg THC

EXPERIMENTAL

Participants will inhale medical cannabis aerosol containing 0.5 mg THC via the Fixed-dose Syqe Inhaler three times a day.

Drug: Medical Cannabis

1.0 mg THC

EXPERIMENTAL

Participants will inhale medical cannabis aerosol containing 1.0 mg THC via the Fixed-dose Syqe Inhaler three times a day.

Drug: Medical Cannabis

Interventions

Medical Cannabis DRUG

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

0.25 mg THC; 0.5 mg THC; 1.0 mg THC

Placebo DRUG

Placebo administered using Fixed-dose Syqe Inhaler.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Presence of skin conditions in the affected dermatome at screening or randomization that could interfere with the evaluation of the neuropathic pain condition.
• Presence of pain not associated with diabetic peripheral neuropathy (DPN) or other neuropathies that may interfere with study assessments.
• 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.
• History or presence of impaired renal function 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.
• 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.
• 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

Sponsors & Collaborators

• Syqe Medical: lead

Study Sites (38)

Innovate Clinical Research

Waitara, New South Wales, 2077, Australia

Location

Western Sydney University NICM Health Research Institute (NICM HRI)

Westmead, New South Wales, 2145, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Rychnov nad Kneznou, Hradec Kralove

Rychnov nad Kněžnou, Hradec Kralove, 516 01, Czechia

Location

Ostrava, Ostrava City

Ostrava, Ostrava City, 71000, Czechia

Location

Plzen, Plzen City

Pilsen, Plzen City, 30100, Czechia

Location

Prague, Praha 12

Prague, Prague, 12000, Czechia

Location

Heidelberg, Baden-Wuerttemberg

Heidelberg, Baden-Wurttemberg, 69115, Germany

Location

Karlsruhe, Baden-Württemberg

Karlsruhe, Baden-Wurttemberg, 76137, Germany

Location

Ulm, Baden-Württemberg

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Hamburg, Hamburg

Hamburg, Free and Hanseatic City of Hamburg, 20253, Germany

Location

Hannover, Lower Saxony

Hanover, Lower Saxony, 30449, Germany

Location

Schwerin, Mecklenburg

Schwerin, Mecklenburg, 19053, Germany

Location

Reinfeld, Schleswig-Holstein

Reinfeld, Schleswig-Holstein, 23858, Germany

Location

Berlin, Berlin 4010

Berlin, State of Berlin, 10629, Germany

Location

Berlin, Berlin

Berlin, State of Berlin, 13187, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 3109601, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

The Edith Wolfson Medical Center

Holon, Tel Aviv, 58100, Israel

Location

Sheba Medical center Hospital

Ramat Gan, Tel Aviv, 5262100, Israel

Location

Barzilai Medical center

Ashkelon, 7830604, Israel

Location

Bnai Zion Medical Center

Haifa, 3104802, Israel

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Beilinson hospital/ Petach Tikva

Petah Tikva, 4941492, Israel

Location

Ziv Medical Center

Safed, 13100, Israel

Location

Swidnica, Dolnoslaskie

Swidnica, Lower Silesian Voivodeship, 58-100, Poland

Location

Sochaczew, Mazowieckie

Sochaczew, Masovian Voivodeship, 96-500, Poland

Location

Warszawa, Mazowieckie 7011

Warsaw, Masovian Voivodeship, 01-018, Poland

Location

Warszawa, Mazowieckie

Warsaw, Masovian Voivodeship, 02-172, Poland

Location

Warszawa, Mazowieckie 7010

Warsaw, Masovian Voivodeship, 02-677, Poland

Location

Katowice, Silesia

Katowice, Silesian Voivodeship, 40-282, Poland

Location

Katowice, Śląsk

Katowice, Silesian Voivodeship, 40-748, Poland

Location

Centrum Medyczne NEUROMED

Bydgoszcz, 85-163, Poland

Location

Centrum Medyczne Pratia Chojnice

Chojnice, 89-600, Poland

Location

Osrodek Badan Klinicznych Neuro-Medic Clinic

Katowice, 40-686, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Neuropathies; Marijuana Abuse; Respiratory Aspiration

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Edith Dekel

  Syqe Medical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 8, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

PL (10); AU (5); CZ (4); DE (11); IL (8)