A novel inhaled treatment
For Painful Diabetic Neuropathy
Is being researched and now
Enrolling new patients
Do you suffer from Painful Diabetic Neuropathy?
A clinical research study is being conducted for adults aged 18-75 with Diabetic Peripheral Neuropathic Pain (DPNP) that:
- Have a current diagnosis of diabetic peripheral neuropathic pain
- No history of Renal or heart disease
- The study doctor decides that you meet all the requirements to be in this study
The study will take place at centers in several countries and will include approximately 192 participants with diabetic nerve pain.
Novel inhaled treatment research for Painful Diabetic Neuropathy is looking for qualified participants
What is Diabetic Neuropathic Pain?
Diabetic neuropathy is a type of nerve damage that can occur with diabetes. The condition most often affects the legs and feet. For some people, symptoms are mild. For others, symptoms can be painful and debilitating. Painful Diabetic Neuropathy makes it painful to get through daily life.
Looking for something more effective? Join a medical research study.
What is the purpose of the clinical study?
This clinical research study evaluates the safety and effectiveness of a novel investigational inhaled treatment for Diabetic Neuropathic Pain. Study participation may include several clinic visits over a period of up to 22 weeks. this study taking place at several sites and countries. The main purpose of this study is to learn how well the study treatment works and how safe it is compared with placebo. A placebo is an inactive material that looks and feels like the study treatment but does not have any activity.
What kind of novel investigational inhaled treatment?
Syqe Medical Ltd. has begun a study of an investigational drug-device combination called Syqe Fixed-dose Inhaler, as a possible treatment for diabetic peripheral neuropathic pain.
Who Can Participate in the Clinical Study?
You are invited to take part in a research study if you have Diabetic Peripheral Neuropathic Pain as well as the following criteria:
- You are between 18 and 75 years old
- You have been diagnosed at least 3 months ago
- You have pain in your feet due to diabetes
- You are currently taking medication(s) for DPNP (duloxetine, gabapentin, or pregabalin) or you had been taking them in the past
- You are not a pregnant or breastfeeding (only relevant to women)
- You are not diagnosed with asthma or COPD (chronic obstructive pulmonary disease)
- You do not have a history of renal or heart disease
This is not a complete list of study requirements.The study doctor will review the full requirements for this study with you.
You must be willing to refrain from driving for the duration of treatment (16 weeks). Reimbursement for travel or meals will be provided as needed.
Participation in the study is subject to medical eligibility criteria and the medical staff’s discretion. Acceptance is not guaranteed.
Participating in a research study is not the same as getting regular medical care. The purpose of a research study is to learn about a possible medical treatment; the purpose of regular medical care is to improve your health. Being in this study does not replace your regular medical care, by participating in this clinical trial you will undergo additional health checks explained and supervised by a study doctor or their staff.
How will the study be conducted?
A double-blind, randomized, placebo-controlled, 4-arm parallel-group, multiple-dose study to assess efficacy and safety of medical cannabis aerosol via the Syqe Inhaler as an add-on treatment of diabetic peripheral neuropathic pain. A Double-blind Randomized study means that no one – not the participant, the study doctor, or any other person involved in the study will know which treatment was received. However, this information will be given to the study doctor if it becomes necessary, for safety measures.
If the study doctor decides that you meet all the requirements to be in this study, you will have a 75% chance of receiving the study medicine and a 25% chance of receiving a placebo. You will be randomly (by chance) assigned to one of 4 groups: 3 treatment groups, each receiving one of three doses, and one control group receiving placebo – all administered by the Syqe Inhaler, 3 times a day.
The amount of cannabis used for each inhalation is much lower than in other cannabis products. The study doctor or study staff will give instructions on how to use the study treatment.
Research stages:
Study periods (22 weeks)
This study will continue 22 weeks and will be divided into 4 periods: a screening period; an up-titration period; a maintenance treatment period; a follow-up period. During each study period, the participants will have visits with the study doctor and/or study coordinator at the site and will receive phone calls from the site.
The Screening Period (14 days)
The initial screening process will be carried out over the phone and can also be done through a digital questionnaire. Those who coordinate the criteria will be invited for a screening visit.
The screening visit will last about 1.5 hours. The candidates will be asked about medical history, previous treatments, and demographics: including questions about their health, diabetic peripheral neuropathic pain, medications or treatments for diabetic peripheral neuropathic pain that they are currently using or have used in the past, alcohol consumption, past and present cannabis use, smoking history, and demographics (age, sex, race, and ethnicity).
The purpose of the screening visit is to decide whether you meet the requirements to take part in this study. If you do not meet the requirements, the study doctor will explain why and will discuss other treatment options with you.
The Up-Titration Period (3 weeks)
The treatment dose starts off low and increases to relevant maintenance dose. During that period the study nurse will contact the patients daily by phone to check on their well-being and to see if they have any side effects. In addition, 2 visits to the study site will be scheduled during this period.
The Maintenance Period (approximately 12 weeks):
The stage where the patients reached their target dose on which they will continue for 14 weeks 3 times per day (morning, afternoon, evening). Inhalations will be possible in intervals of 3 hours or more between the inhalations. During the maintenance period of 14 weeks, the patients visit the study site every 2 weeks and receive phone calls every other week. The patients will ask to bring the inhaler with them to all study site visits so that the study staff could assess their treatment adherence.
The Follow-Up Pperiod (approximately 4 weeks)
During the 4-weeks follow-up period, after the study treatment has finished the patients will visit the study site 3 times and the study nurse will contact them twice by phone. At the end of this period the study end.
The Syqe Inhaler
The Syqe Inhaler is a portable, hand-held, battery-operated, software-controlled device. It heats the medical cannabis and delivers a fixed-dose aerosol. If you are considered eligible to participate in the study you will receive a kit, containing the inhaler, a mouthpiece and a charging cable and power adapter. In addition, you will receive a separate box, containing a rigid case to protect the inhaler when it is not used or being charged.
The cartridge inside the inhaler consists of 60 vapor chips containing the medical-grade cannabis. At each site visit, the used cartridge will be removed, and a new one will be placed into the device by the study staff. After 3 cartridges have been used, the study staff will also replace the mouthpiece of the device. Upon inhalation through the mouth, aerosol is rapidly absorbed through the lungs into the blood stream. The cannabis-derived aerosol is being investigated for the reduction of diabetic pain.
The inhaler holds the following certificates: CE Mark European certification TÜV SÜD GmbH, of Germany (NB number #0123) by the EU Notified Body (NB), and the Australian ARTG approval.
Where Is The Research Clinic Closest To You?
FAQ
How long will my participation in this study last?
You will be in this study for approximately 22 weeks, and you will need to come to the study site at least 14 times over this period.
What should I expect to happen in this study?
This study will last 22 weeks and will be divided into 4 periods: a screening period; an up-titration period; a maintenance treatment period; a follow-up period. During each study period, you will meet with the study doctor and/or study coordinator at the site and will receive phone calls from the site.
What happens during the screening period?
The purpose of the screening visit is to decide whether you meet the requirements to take part in this study. If you do not meet the requirements, the study doctor will explain why and will discuss other treatment options with you. The screening visit will last about 1.5 hours, during which you will read and sign an informed consent form (agreeing to participate), provide information on your medical history, diabetic neuropathic pain, general well-being, mental state, and demographics, and go through a full physical examination. Women of childbearing age will undergo a pregnancy test.
What do I have to do during this study?
During this study, you will have some responsibilities. In general, you will be asked:
- During the screening period: to cooperate with the research doctor, even on things that seem “small”, including future surgeries or treatments.
- During the study period: attend visits, answer calls from the staff, follow the instructions accurately, use the inhaler as instructed, fill out an electronic diary and report any medical changes or side effects. In addition, it is forbidden to drive or operate machinery while using the study drug.
- After the end of the study: report your medical condition to the team in accordance with the instructions
Will I be given cannabis?
Each participant has a 75% chance (3 of 4 patients) of receiving medical cannabis aerosol, and a 25% chance (1 of 4 patients) of receiving a placebo. No one will know which treatment you are receiving: Neither you nor the staff at the research site will know if your treatment is cannabis or placebo. The amount of cannabis used per inhalation is much lower than in other cannabis products that you may have experienced in the past or heard of…
What are the possible risks and discomforts?
As with any study, there may be side effects – mild or severe. It is important to report every change, even a small one. The professional team will accompany you throughout the entire process and will be able to offer appropriate treatment if necessary. So far, all reported side effects have been mild and reversible. You can have an extensive conversation about this topic with the study doctor during the screening process.
Can pregnant or breastfeeding women participate in the study?
Unfortunately, no. If you are pregnant, planning to become pregnant, or breastfeeding a child, you cannot take part in this study.
What are the benefits of participating in this study?
There is no guarantee that your medical condition will benefit from this study. However, you will be helping others by contributing to medical research. You may feel that you are benefiting in the following ways:
- Your condition will be monitored by a professional medical team during your participation in the study. However, having your condition evaluated as part of the study is not a substitute for careful evaluation, ongoing medical care, or follow-up by your attending doctor.
- The study treatment may help to relieve your symptoms.
May I stop my participation after the study has begun?
Participation in this study is voluntary, and you may leave the study at any time and for any reason, and your usual medical care or benefits to which you are entitled will not be affected. If you consider discontinuing
participation in the study, you should contact the study doctor to discuss the safest way to leave the study. This may include completing some final tests. You should also contact your attending doctor so that they can provide you with the best possible follow-up care
What medical care will I receive when my participation in this study stops?
When you leave the study, you will be under the care of your attending doctor who will decide the best way to treat your diabetic peripheral neuropathic pain. The study treatment will no longer be available to you.
Will I be informed of the study results?
You have the right to be informed of the overall results of this study when it is concluded.
