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A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
Sponsor: Syqe Medical
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
192
Start Date
2024-11-14
Completion Date
2025-11-08
Last Updated
2025-04-18
Healthy Volunteers
No
Conditions
Interventions
Medical Cannabis
Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.
Placebo
Placebo administered using Fixed-dose Syqe Inhaler.
Locations (38)
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
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