A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
NCT ID: NCT06490445
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
192 participants
INTERVENTIONAL
2024-11-14
2025-11-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants will receive placebo, inhaled TID via the Fixed-dose Syqe Inhaler.
Placebo
Placebo administered using Fixed-dose Syqe Inhaler.
0.25 mg THC
Participants will inhale medical cannabis aerosol containing 0.25 mg THC via the Fixed-dose Syqe Inhaler three times a day.
Medical Cannabis
Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.
0.5 mg THC
Participants will inhale medical cannabis aerosol containing 0.5 mg THC via the Fixed-dose Syqe Inhaler three times a day.
Medical Cannabis
Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.
1.0 mg THC
Participants will inhale medical cannabis aerosol containing 1.0 mg THC via the Fixed-dose Syqe Inhaler three times a day.
Medical Cannabis
Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.
Interventions
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Medical Cannabis
Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.
Placebo
Placebo administered using Fixed-dose Syqe Inhaler.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Syqe Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Edith Dekel
Role: STUDY_DIRECTOR
Syqe Medical Ltd.
Locations
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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, City state of 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
The Edith Wolfson Medical Center
Holon, Tel Aviv, Israel
Sheba Medical center Hospital
Ramat Gan, Tel Aviv, Israel
Barzilai Medical center
Ashkelon, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Beilinson hospital/ Petach Tikva
Petah Tikva, , Israel
Ziv Medical Center
Safed, , Israel
Swidnica, Dolnoslaskie
Swidnica, Lower Silesian Voivodeship, Poland
Sochaczew, Mazowieckie
Sochaczew, Masovian Voivodeship, Poland
Warszawa, Mazowieckie 7011
Warsaw, Masovian Voivodeship, Poland
Warszawa, Mazowieckie
Warsaw, Masovian Voivodeship, Poland
Warszawa, Mazowieckie 7010
Warsaw, Masovian Voivodeship, Poland
Katowice, Silesia
Katowice, Silesian Voivodeship, Poland
Katowice, Śląsk
Katowice, Silesian Voivodeship, Poland
Centrum Medyczne NEUROMED
Bydgoszcz, , Poland
Centrum Medyczne Pratia Chojnice
Chojnice, , Poland
Osrodek Badan Klinicznych Neuro-Medic Clinic
Katowice, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-508932-68-00
Identifier Type: CTIS
Identifier Source: secondary_id
Syqe-004
Identifier Type: -
Identifier Source: org_study_id
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