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Diabetic Peripheral Neuropathic PainPhase 2NCT06490445

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

A Phase 2 study testing Medical Cannabis in people with Diabetic Peripheral Neuropathic Pain, run by Syqe Medical at 38 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetic Peripheral Neuropathic Pain
What is being tested?
Medical Cannabis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
38 sitesin 5 countries
Study dates
14 Nov 2024to 24 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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
  • History of familial long QT syndrome or known family history of ventricular arrythmia.
  • Acute ischemic changes.
  • History or presence of mental illness evidenced as defined in the protocol.
  • Abnormal neurological condition or abnormal neurological examination other than related to DPN as judged by the investigator at screening that impacts the assessment of study endpoints.

Trial locations and contacts

38 sites in 5 countries.

38 sites in 5 countries

Germany11 sites

  • Berlin, Berlin 4010

    Berlin, State of Berlin, 10629

  • Berlin, Berlin

    Berlin, State of Berlin, 13187

  • Klinische Forschung Dresden GmbH

    Dresden, 3109601

  • Hamburg, Hamburg

    Hamburg, Free and Hanseatic City of Hamburg, 20253

  • Hannover, Lower Saxony

    Hanover, Lower Saxony, 30449

  • Heidelberg, Baden-Wuerttemberg

    Heidelberg, Baden-Wurttemberg, 69115

  • Karlsruhe, Baden-Württemberg

    Karlsruhe, Baden-Wurttemberg, 76137

  • Reinfeld, Schleswig-Holstein

    Reinfeld, Schleswig-Holstein, 23858

  • Schwerin, Mecklenburg

    Schwerin, Mecklenburg, 19053

  • Klinische Forschung Schwerin GmbH

    Schwerin, 19055

  • Ulm, Baden-Württemberg

    Ulm, Baden-Wurttemberg, 89073

Other trials in Germany

Poland10 sites

  • Centrum Medyczne NEUROMED

    Bydgoszcz, 85-163

  • Centrum Medyczne Pratia Chojnice

    Chojnice, 89-600

  • Katowice, Silesia

    Katowice, Silesian Voivodeship, 40-282

  • Katowice, Śląsk

    Katowice, Silesian Voivodeship, 40-748

  • Osrodek Badan Klinicznych Neuro-Medic Clinic

    Katowice, 40-686

  • Sochaczew, Mazowieckie

    Sochaczew, Masovian Voivodeship, 96-500

  • Swidnica, Dolnoslaskie

    Swidnica, Lower Silesian Voivodeship, 58-100

  • Warszawa, Mazowieckie 7011

    Warsaw, Masovian Voivodeship, 01-018

  • Warszawa, Mazowieckie

    Warsaw, Masovian Voivodeship, 02-172

  • Warszawa, Mazowieckie 7010

    Warsaw, Masovian Voivodeship, 02-677

Other trials in Poland

Israel8 sites

  • Barzilai Medical center

    Ashkelon, 7830604

  • Bnai Zion Medical Center

    Haifa, 3104802

  • Rambam Medical Center

    Haifa, 3109601

  • The Edith Wolfson Medical Center

    Holon, Tel Aviv, 58100

  • Hadassah Medical Center

    Jerusalem, 91120

  • Beilinson hospital/ Petach Tikva

    Petah Tikva, 4941492

  • Sheba Medical center Hospital

    Ramat Gan, Tel Aviv, 5262100

  • Ziv Medical Center

    Safed, 13100

Other trials in Israel

Australia5 sites

  • Emeritus Research

    Camberwell, Victoria, 3124

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Innovate Clinical Research

    Waitara, New South Wales, 2077

  • Western Sydney University NICM Health Research Institute (NICM HRI)

    Westmead, New South Wales, 2145

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Czechia4 sites

  • Ostrava, Ostrava City

    Ostrava, Ostrava City, 71000

  • Plzen, Plzen City

    Pilsen, Plzen City, 30100

  • Prague, Praha 12

    Prague, Prague, 12000

  • Rychnov nad Kneznou, Hradec Kralove

    Rychnov nad Kněžnou, Hradec Kralove, 516 01

Other trials in Czechia

About this study

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

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.

Read the detailed description

This study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of medical cannabis aerosol inhaled via the Syqe Inhaler at nominal doses of 0 (placebo), 0.25, 0.5, and 1.0 mg TID of Δ9-THC added on to standard of care for treatment of DPNP.

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.

Being tested
Medical Cannabis, Placebo
Keywords
Diabetes, Neuropathy, Painful diabetic neuropathy, Chronic Neuropathic Pain, DPNP, Cannabis, Medical cannabis, Inhaled, Aerosol, Placebo, Randomized, Double-blind
Medical subject headings
Diabetes Mellitus, Diabetic Neuropathies, Marijuana Abuse, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical CannabisDrug

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

  • PlaceboDrug

    Placebo administered using Fixed-dose Syqe Inhaler.

Study groups in NCT06490445
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive placebo, inhaled TID via the Fixed-dose Syqe Inhaler.
Receives: Drug: Placebo
0.25 mg THCExperimentalParticipants will inhale medical cannabis aerosol containing 0.25 mg THC via the Fixed-dose Syqe Inhaler three times a day.
Receives: Drug: Medical Cannabis
0.5 mg THCExperimentalParticipants will inhale medical cannabis aerosol containing 0.5 mg THC via the Fixed-dose Syqe Inhaler three times a day.
Receives: Drug: Medical Cannabis
1.0 mg THCExperimentalParticipants will inhale medical cannabis aerosol containing 1.0 mg THC via the Fixed-dose Syqe Inhaler three times a day.
Receives: Drug: Medical Cannabis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and at Week 15

Secondary outcomes (23)

  1. Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI)

    The NPSI is a 12-items patient reported outcome (PRO) measure that contains 10 descriptors representing 5 dimensions of pain (burning pain, deep/pressing pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia), and 2 temporal items designed to assess pain duration and the number of pain paroxysms. Total score range for NPSI is 0-100, higher scores indicate more severity.

    Measured: Baseline up to Week 19

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

    The BPI-SF allows participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function using a 0 to 10 NRS. A higher score indicates more severity or more interference.

    Measured: Baseline up to Week 19

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

    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.

    Measured: Baseline up to Week 19

  4. 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

    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.

    Measured: Baseline up to Week 19

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

    Measured: Baseline up to Week 19

  6. Proportion of Participants With Adverse Events (AEs) Leading to Study Treatment Discontinuation and Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs).

    Measured: Baseline up to Week 19

  7. Assessment of Diabetic Neuropathy using the Michigan Neuropathy Screening Instrument (MNSI) - Part B

    The MNSI Part B consists of visual inspection of the feet and assessment of ankle reflexes, vibration sense, and monofilament testing. The measure is a score between 0 (normal) and 10 (most severe).

    Measured: Baseline up to Week 19

  8. Assessment of Suicidal Ideation and Behavior using the Columbia Suicide Severity Rating Scale (C-SSRS)

    The C-SSRS is a semi-structured interview to assess the presence and severity of suicidal ideation and behavior.

    Measured: Baseline up to Week 19

  9. Assessment of Withdrawal Symptoms After Termination of Study Treatment using the Study Medication Withdrawal Questionnaire Version 2 (SMWQ V2)

    The SMWQ V2 is a 10-item patient-reported measure, where responses related to withdrawal symptoms are rated on 5-level Lickert scales between 0 (not at all) and 4 (very much).

    Measured: Baseline up to Week 19

  10. Number of Participants With Clinically Significant Abnormal Lung Function Measured using Spirometry

    Spirometry is a test that measures how much air can be breathed out in one forced breath. It is used to measure acute effects of study treatment on lung function. Spirometry testing will include measurement of forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and FEV1/FVC.

    Measured: Baseline up to Week 19

  11. Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)

    An ECG is a test that records the electrical activity of the heart. It is used to measure acute effects of study treatment on heart function.

    Measured: Baseline up to Week 19

  12. Number of Participants With Clinically Significant Abnormality in Blood and Urine Parameters

    A variety of laboratory tests will be used to identify any clinically significant abnormalities.

    Measured: Baseline up to Week 19

  13. Pharmacokinetics - Ctrough

    Pre-dose plasma concentration (Ctrough) of Δ9-THC, cannabidiol, cannabinol, 11-OH-THC, and 11-COOH-THC.

    Measured: At selected visits from baseline up to Week 16

  14. Pharmacokinetics - Cmax,ss

    Maximum observed plasma steady state concentration (Cmax,ss) for Δ9-THC, cannabidiol, cannabinol, 11-OH-THC, and 11-COOH-THC.

    Measured: At selected visits from baseline up to Week 16

  15. Pharmacokinetics - Tmax,ss

    Time to reach maximum observed plasma steady state concentration (Tmax,ss) for Δ9-THC, cannabidiol, cannabinol, 11-OH-THC, and 11-COOH-THC.

    Measured: At selected visits from baseline up to Week 16

  16. Pharmacokinetics - AUC

    Area under the concentration-time curve (AUC) for Δ9-THC, cannabidiol, cannabinol, 11-OH-THC, and 11-COOH-THC.

    Measured: At selected visits from baseline up to Week 16

  17. Proportion of Participants who Need Rescue Medication for the Treatment of DPNP

    Measured: Baseline up to Week 19

  18. Frequency of Rescue Medication Taken for the Treatment of DPNP

    Measured: Baseline up to Week 19

  19. Amount of Rescue Medication Taken for the Treatment of DPNP

    Measured: Baseline up to Week 19

  20. Time to First Intake of Rescue Medication Taken for the Treatment of DPNP

    Measured: Baseline up to Week 19

  21. Change From Baseline in Weekly-mean 24-hour Sleep Score Using the Daily Sleep Interference Scale (DSIS)

    The DSIS diary consists of an 11-point Likert scale with which participants assess how pain has interfered with their sleep during the past 24 hours. On this scale a 0 indicates "pain does not interfere with sleep" and 10 indicates "pain completely interferes with sleep." A higher score indicates more inference of pain with sleep.

    Measured: Baseline up to Week 19

  22. Change From Baseline in Sleep Score Using the Pain and Sleep Questionnaire-3 (PSQ-3)

    The PSQ-3, also called Chronic Pain Sleep Inventory©, is a patient-reported 3-item index to assess the impact of chronic pain on sleep over the past 7 days. Each item is reported on a visual analog scale (VAS) between "never" and "always". The score ranges from 0 to 100.

    Measured: Baseline up to Week 19

  23. Change From Baseline in Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Profile Total Score

    PROMIS-29 Profile v2.1 is a set of person-centered measures that evaluates and monitors physical, mental, and social health. PROMIS-29 Profile v2.1 consists of 7 domains with a total of 29 questions answered on Lickert scales.

    Measured: Baseline up to Week 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2024
  2. Study start14 Nov 2024
  3. Primary completion26 May 2026
  4. Study completion24 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06490445
Sponsor's protocol ID
Syqe-004
Other IDs
2023-508932-68-00, 2023
Status last verified
Jun 2026
First submitted
30 Jun 2024
Last updated
29 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Medical Cannabis in people with Diabetic Peripheral Neuropathic Pain, run by Syqe Medical at 38 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Germany, Poland, Israel, Australia, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Weekly-mean 24-hour Average Pain Score on the Numeric Rating Scale (NRS) at Week 15 (time frame: Baseline and at Week 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06490445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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