Ongoing Clinical Trials for Diabetic Neuropathy
There are currently 7 clinical trials studying treatments for diabetic neuropathy, a condition causing nerve damage and pain in people with diabetes. These trials are testing various medications including botulinum toxin injections, medical cannabis, and experimental drugs, with studies taking place across multiple European countries including Germany, Poland, France, Denmark, and others.
Clinical trial locations
- Austria
- Bulgaria
- Czechia
- Denmark
- Espagne
- France
- Germany
- Study on Medical Cannabis Aerosol for Treating Diabetic Nerve Pain in Patients Using Syqe Inhaler
- Study on the Effectiveness and Safety of VX-993 and Pregabalin for Pain Relief in Patients with Diabetic Peripheral Neuropathy
- Study on the Effectiveness and Safety of AP707, Amitriptyline, and Capsaicin for Patients with Chronic Pain from Diabetic Neuropathy
- Study on GSK3858279 for Adults with Chronic Diabetic Nerve Pain
- Study on the Effectiveness of ODM-111 and Paracetamol for Chronic Pain in Patients with Diabetic Peripheral Neuropathy
- Hungary
- Italy
- Poland
- Spain
Study of Incobotulinumtoxin-A Injections for Diabetic Neuropathic Pain in the Lower Limbs
This study, conducted in Denmark, is testing whether incobotulinumtoxin-A (also known as Xeomin) can help relieve nerve pain in the lower legs caused by diabetes. This is a form of botulinum toxin that is injected around the nerves to see if it can reduce pain.
Who can participate: The study is looking for adults aged 18 or older who have been diagnosed with either type I or type II diabetes. Participants must have nerve pain in both legs that has been present for at least 6 months and rates at least 4 out of 10 on a pain scale. The pain must be confirmed as neuropathic pain through nerve conduction studies. Participants need to be on a stable pain treatment plan for at least one month and must be able to speak, read, and understand Danish.
Who cannot participate: The study excludes people who do not have nerve pain in the lower legs due to diabetes, those outside the specified age range, and individuals considered part of a vulnerable population who might need special protection or care.
What the study aims to do: The main goal is to investigate how effective and safe these injections are for managing pain. Participants will receive either the actual treatment or a placebo over a 24-week period. Regular check-ups will monitor pain levels, muscle strength, quality of life, and any side effects.
Study on Medical Cannabis Aerosol for Treating Diabetic Nerve Pain in Patients Using Syqe Inhaler
This trial, taking place in Poland, Germany, and Czechia, is testing a medical cannabis aerosol for treating nerve pain in the feet caused by diabetes. The cannabis is inhaled using a special device called the Syqe Inhaler.
Who can participate: Adults between 18 and 75 years old with a body mass index between 18 and 40 kg/m² can join. Participants must have nerve pain in the feet for at least 6 months with sufficient pain intensity. They must be on stable diabetes medications for at least 3 months and agree not to use any other cannabis products during the study. Participants must not be current cannabis users or must not have used cannabis within 3 months before screening.
Who cannot participate: Pregnant or breastfeeding women, people with severe mental health disorders like schizophrenia, those with cannabis allergies, recent cannabis users, individuals with substance abuse history, those with significant heart, liver, or kidney problems, recent surgery patients, and people with epilepsy are excluded.
What the study aims to do: The study will test different doses of cannabis aerosol (0.25 mg, 0.5 mg, or 1.0 mg of THC) compared to a placebo. Participants will inhale the treatment three times daily for 15 weeks. Researchers will monitor pain levels, symptom changes, and any side effects to determine if this treatment can effectively reduce pain and improve quality of life.
Study on the Effectiveness and Safety of VX-993 and Pregabalin for Pain Relief in Patients with Diabetic Peripheral Neuropathy
This study in France, Italy, and Germany is testing a new medication called VX-993, which works by blocking specific sodium channels thought to play a role in pain sensation. The study will compare it with pregabalin, a commonly used nerve pain medication, and a placebo.
Who can participate: The study seeks adults with type 1 or type 2 diabetes who have nerve pain in both legs that has lasted at least one year. Participants must have optimized blood sugar control with HbA1c levels of 9% or less and be on stable diabetes medication for at least 3 months.
Who cannot participate: People without nerve pain from diabetes, those outside the specified age range, and vulnerable populations requiring special protection are excluded.
What the study aims to do: The trial will evaluate how well different doses of VX-993 reduce pain compared to pregabalin and placebo. Participants will take oral tablets for up to 12 weeks, with regular assessments of pain levels, side effects, laboratory tests, and vital signs. The main goal is to see if VX-993 can significantly reduce pain and be well tolerated by patients.
Study on the Effectiveness and Safety of AP707, Amitriptyline, and Capsaicin for Patients with Chronic Pain from Diabetic Neuropathy
This Austrian and German study is testing AP707 as an additional treatment for chronic pain caused by nerve damage from diabetes. The medication is administered as a sublingual spray, meaning it is sprayed under the tongue.
Who can participate: Adults aged 18 or older who have experienced chronic pain due to nerve damage from diabetes for at least 3 months can participate. Pain must be moderate to severe, rating 5 or more on a 0-10 scale. Participants need optimized pain treatment, a life expectancy of more than 1 year, good command of German to understand questionnaires, and willingness to use reliable contraception during the study.
Who cannot participate: People without chronic pain from diabetic nerve damage, those outside the age range, and vulnerable populations are excluded.
What the study aims to do: The 52-week trial will test AP707 against a placebo to evaluate effectiveness in pain relief. Participants will undergo regular assessments including pain scales, quality of life questionnaires, and psychological distress measures. The study aims to determine if AP707 can provide significant additional pain relief when added to current treatment plans.
Study on Eptinezumab for Painful Diabetic Neuropathy in Adults
This Danish study is testing eptinezumab, a CGRP monoclonal antibody, for reducing pain intensity in people with painful nerve damage from diabetes. The medication is given through an intravenous infusion directly into the vein.
Who can participate: Adults between 18 and 75 years old with confirmed diabetic nerve damage can join. They must have symmetric pain in both lower legs that has lasted more than 6 months, with an average pain score of 4 or higher on a 0-10 scale during the week before the study.
Who cannot participate: People without painful diabetic nerve damage, those outside the age range, and vulnerable populations are excluded.
What the study aims to do: Over 24 weeks, the study will monitor whether eptinezumab reduces pain compared to placebo. Participants will keep daily pain diaries and complete regular assessments including the Neuropathic Pain Scale. Researchers will evaluate pain relief at weeks 12 and 24 to determine the medication’s effectiveness.
Study on GSK3858279 for Adults with Chronic Diabetic Nerve Pain
This study across Germany, Poland, Spain, and France is testing GSK3858279, administered as a subcutaneous injection (under the skin), for managing nerve pain from diabetes.
Who can participate: Adults aged 18 to 75 with type I or type II diabetes and nerve pain in the feet or legs for at least 6 months can participate. Pain must rate between 4 and 9 on a 0-10 scale. Participants need HbA1c levels less than 97 mmol/mol (less than 11%), stable diabetes medication for at least 30 days, BMI between 18 and 40 kg/m², and history of inadequate pain relief from standard treatments. They must be willing to use patient diaries and follow all study procedures.
Who cannot participate: People without nerve pain from diabetes, those outside the age range, and vulnerable populations are excluded.
What the study aims to do: The 12-week trial will compare GSK3858279 with placebo to assess pain reduction, safety, and how the body processes the medication. Regular assessments will monitor pain levels using numeric scales, with participants recording daily pain in electronic diaries. The study will also track side effects and overall tolerability.
Study on the Effectiveness of ODM-111 and Paracetamol for Chronic Pain in Patients with Diabetic Peripheral Neuropathy
This study in Poland, Bulgaria, Hungary, Germany, and Czechia is testing ODM-111, an oral tablet medication, for managing chronic pain from nerve damage caused by diabetes.
Who can participate: Men and women aged 18 to 80 with BMI between 18 and 45 kg/m² can participate. They must have had type 1 or type 2 diabetes for at least 6 months with well-controlled blood sugar for 3 months before screening. Nerve pain must have been present for at least 6 months, mainly in the legs, with specific pain intensity levels on a 0-10 scale. Participants need a certain DN4 questionnaire score and must agree to use highly effective birth control if sexually active and not permanently sterilized.
Who cannot participate: People without chronic pain from diabetic nerve damage, those outside the age range, unwilling to follow procedures, pregnant or breastfeeding women, those with serious interfering health conditions, current participants in other trials, recent or planned surgery patients, those with substance abuse history, and people allergic to the study medication are excluded.
What the study aims to do: Over six weeks, the study will compare ODM-111 with placebo to evaluate effectiveness in reducing pain. Participants will record daily pain levels using an electronic diary. The study also involves Para-Tabs containing paracetamol. Researchers aim to determine if ODM-111 can improve quality of life and provide better pain management options for those with chronic nerve pain from diabetes.
Summary
The seven ongoing clinical trials for diabetic neuropathy represent a diverse range of treatment approaches, from traditional pharmaceutical compounds to innovative therapies like medical cannabis and botulinum toxin injections. A notable concentration of trials is taking place in Germany, which hosts five of the seven studies, followed by Poland with three trials. This suggests strong research infrastructure and patient recruitment capabilities in these countries.
The investigational drugs being tested work through various mechanisms, including sodium channel inhibition (VX-993), CGRP blocking (eptinezumab), cannabinoid receptors (medical cannabis aerosol), and neurotoxin effects (incobotulinumtoxin-A). Most studies require participants to have experienced pain for at least six months and maintain stable diabetes management, typically with HbA1c levels below 9-11%.
Common inclusion criteria across trials include age ranges typically from 18 to 75 or 80 years, confirmed diabetes diagnosis (type 1 or 2), and moderate to severe pain ratings of at least 4-5 on a 0-10 scale. Most studies exclude pregnant or breastfeeding women, vulnerable populations, and individuals with serious comorbidities. The duration of these trials ranges from 12 weeks to 52 weeks, with regular pain assessments being a central component of monitoring effectiveness.
