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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06490445




Registration number
NCT06490445
Ethics application status
Date submitted
30/06/2024
Date registered
8/07/2024

Titles & IDs
Public title
A Study of Medical Cannabis Aerosol Via the Fixed-dose Syqe Inhaler as an Add-on Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
Scientific 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
Secondary ID [1] 0 0
2023-508932-68-00
Secondary ID [2] 0 0
Syqe-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Peripheral Neuropathic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Diabetes
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Medical Cannabis
Treatment: Drugs - Placebo

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

Experimental: 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.

Experimental: 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.

Experimental: 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.


Treatment: Drugs: Medical Cannabis
Syqe cartridge containing medical cannabis (Bedrocan®) administered using Fixed-dose Syqe Inhaler.

Treatment: Drugs: Placebo
Placebo administered using Fixed-dose Syqe Inhaler.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Weekly-mean 24-hour Average Pain Score on the Numeric Rating Scale (NRS) at Week 15
Timepoint [1] 0 0
Baseline and at Week 15
Secondary outcome [1] 0 0
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI)
Timepoint [1] 0 0
Baseline up to Week 19
Secondary outcome [2] 0 0
Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Scale
Timepoint [2] 0 0
Baseline up to Week 19
Secondary outcome [3] 0 0
Change From Baseline in Weekly-mean 24-hour Average, Worst and Least Pain Score on the NRS
Timepoint [3] 0 0
Baseline up to Week 19
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline up to Week 19
Secondary outcome [5] 0 0
Proportion of Participants with Treatment-emergent Adverse Events (TEAEs) and Their Severity
Timepoint [5] 0 0
Baseline up to Week 19
Secondary outcome [6] 0 0
Proportion of Participants With Adverse Events (AEs) Leading to Study Treatment Discontinuation and Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs).
Timepoint [6] 0 0
Baseline up to Week 19
Secondary outcome [7] 0 0
Assessment of Diabetic Neuropathy using the Michigan Neuropathy Screening Instrument (MNSI) - Part B
Timepoint [7] 0 0
Baseline up to Week 19
Secondary outcome [8] 0 0
Assessment of Suicidal Ideation and Behavior using the Columbia Suicide Severity Rating Scale (C-SSRS)
Timepoint [8] 0 0
Baseline up to Week 19
Secondary outcome [9] 0 0
Assessment of Withdrawal Symptoms After Termination of Study Treatment using the Study Medication Withdrawal Questionnaire Version 2 (SMWQ V2)
Timepoint [9] 0 0
Baseline up to Week 19
Secondary outcome [10] 0 0
Number of Participants With Clinically Significant Abnormal Lung Function Measured using Spirometry
Timepoint [10] 0 0
Baseline up to Week 19
Secondary outcome [11] 0 0
Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)
Timepoint [11] 0 0
Baseline up to Week 19
Secondary outcome [12] 0 0
Number of Participants With Clinically Significant Abnormality in Blood and Urine Parameters
Timepoint [12] 0 0
Baseline up to Week 19
Secondary outcome [13] 0 0
Pharmacokinetics - Ctrough
Timepoint [13] 0 0
At selected visits from baseline up to Week 16
Secondary outcome [14] 0 0
Pharmacokinetics - Cmax,ss
Timepoint [14] 0 0
At selected visits from baseline up to Week 16
Secondary outcome [15] 0 0
Pharmacokinetics - Tmax,ss
Timepoint [15] 0 0
At selected visits from baseline up to Week 16
Secondary outcome [16] 0 0
Pharmacokinetics - AUC
Timepoint [16] 0 0
At selected visits from baseline up to Week 16
Secondary outcome [17] 0 0
Proportion of Participants who Need Rescue Medication for the Treatment of DPNP
Timepoint [17] 0 0
Baseline up to Week 19
Secondary outcome [18] 0 0
Frequency of Rescue Medication Taken for the Treatment of DPNP
Timepoint [18] 0 0
Baseline up to Week 19
Secondary outcome [19] 0 0
Amount of Rescue Medication Taken for the Treatment of DPNP
Timepoint [19] 0 0
Baseline up to Week 19
Secondary outcome [20] 0 0
Time to First Intake of Rescue Medication Taken for the Treatment of DPNP
Timepoint [20] 0 0
Baseline up to Week 19
Secondary outcome [21] 0 0
Change From Baseline in Weekly-mean 24-hour Sleep Score Using the Daily Sleep Interference Scale (DSIS)
Timepoint [21] 0 0
Baseline up to Week 19
Secondary outcome [22] 0 0
Change From Baseline in Sleep Score Using the Pain and Sleep Questionnaire-3 (PSQ-3)
Timepoint [22] 0 0
Baseline up to Week 19
Secondary outcome [23] 0 0
Change From Baseline in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Profile Total Score
Timepoint [23] 0 0
Baseline up to Week 19

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/11/2025
Actual
Sample size
Target
192
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Innovate Clinical Research - Waitara
Recruitment hospital [2] 0 0
Western Sydney University NICM Health Research Institute (NICM HRI) - Westmead
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Emeritus Research - Camberwell
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2077 - Waitara
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Hradec Kralove
Country [2] 0 0
Czechia
State/province [2] 0 0
Ostrava City
Country [3] 0 0
Czechia
State/province [3] 0 0
Plzen City
Country [4] 0 0
Czechia
State/province [4] 0 0
Praha
Country [5] 0 0
Germany
State/province [5] 0 0
Baden-Wuerttemberg
Country [6] 0 0
Germany
State/province [6] 0 0
Baden-Württemberg
Country [7] 0 0
Germany
State/province [7] 0 0
Lower Saxony
Country [8] 0 0
Germany
State/province [8] 0 0
Mecklenburg
Country [9] 0 0
Germany
State/province [9] 0 0
Schleswig-Holstein
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Dresden
Country [12] 0 0
Germany
State/province [12] 0 0
Hamburg
Country [13] 0 0
Germany
State/province [13] 0 0
Schwerin
Country [14] 0 0
Israel
State/province [14] 0 0
Tel Aviv
Country [15] 0 0
Israel
State/province [15] 0 0
Ashkelon
Country [16] 0 0
Israel
State/province [16] 0 0
Haifa
Country [17] 0 0
Israel
State/province [17] 0 0
Jerusalem
Country [18] 0 0
Israel
State/province [18] 0 0
Petach Tikva
Country [19] 0 0
Israel
State/province [19] 0 0
Safed
Country [20] 0 0
Poland
State/province [20] 0 0
Dolnoslaskie
Country [21] 0 0
Poland
State/province [21] 0 0
Mazowieckie
Country [22] 0 0
Poland
State/province [22] 0 0
Silesia
Country [23] 0 0
Poland
State/province [23] 0 0
Bydgoszcz
Country [24] 0 0
Poland
State/province [24] 0 0
Chojnice
Country [25] 0 0
Poland
State/province [25] 0 0
Katowice
Country [26] 0 0
Poland
State/province [26] 0 0
Slask

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Syqe Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edith Dekel
Address 0 0
Syqe Medical Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Head of Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
+972 3-376-7338
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06490445