Ongoing Clinical Trials for Peripheral Neuropathy
Currently, there are 9 ongoing clinical trials for peripheral neuropathy across multiple countries, testing various treatments including ozone therapy, capsaicin patches, duloxetine, brimonidine gel, psilocybin, botulinum toxin, immunoglobulins, and aldose reductase inhibitors for different types of nerve damage caused by chemotherapy, autoimmune conditions, and genetic disorders.
Clinical trial locations
- Bulgaria
- Czechia
- Denmark
- France
- Study Comparing Capsaicin Patch and Duloxetine for Patients with Chemotherapy-Induced Peripheral Neuropathy
- Study of brimonidine tartrate gel to prevent nerve damage in breast cancer patients receiving taxane treatment
- Study Comparing Gadoquatrane with Gadoteric Acid, Gadoteridol, and Gadobutrol for MRI in Patients with Non-CNS Conditions
- Study on the Effectiveness of Human Normal Immunoglobulin for Treating Painful Nerve Damage in Patients with Primary Sjögren’s Syndrome
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Spain
- Sweden
Ozone Treatment for Numbness and Tingling from Chemotherapy in Patients with Peripheral Neuropathy: A Clinical Trial
This trial is being conducted in Spain and focuses on using ozone therapy to reduce numbness and tingling caused by chemotherapy. The treatment is administered rectally as a mixture of ozone and oxygen over a 16-week period.
Who can participate: Adults aged 18 or older who have experienced moderate to severe numbness or tingling for at least 3 months after completing chemotherapy. The cancer must be stable or in remission, and participants must have a life expectancy of at least 6 months. Women of childbearing age must use effective birth control and have a negative pregnancy test before starting.
Who cannot participate: People without numbness or tingling caused by chemotherapy, those with mild symptoms only, and patients who have received neurotoxic chemotherapy within the last 3 months.
Main goal: The study aims to determine if ozone therapy, when added to standard care, can improve symptoms of numbness and tingling and enhance quality of life for patients with chemotherapy-induced nerve damage.
Treatment being tested: Ozone therapy is administered through rectal insufflation. The trial will assess whether this form of oxygen therapy can reduce uncomfortable sensations and improve patients’ daily functioning.
Study Comparing Capsaicin Patch and Duloxetine for Patients with Chemotherapy-Induced Peripheral Neuropathy
This French trial compares two different treatments for painful nerve damage caused by chemotherapy: a capsaicin patch applied to the skin and duloxetine taken as a pill.
Who can participate: Adults with painful nerve damage from chemotherapy with taxanes or platinum-based drugs. The pain must have lasted at least 1 month after completing chemotherapy, with a severity score of 4 or higher on a 10-point scale. The skin where the patch will be applied must be healthy and non-irritated. Other nerve pain medications must have been at stable doses for at least 4 weeks.
Who cannot participate: People with nerve pain from other causes, those using conflicting pain treatments, patients with severe skin or heart conditions, those with uncontrolled high blood pressure, and pregnant or breastfeeding women.
Main goal: To determine which treatment provides better pain relief after 5 weeks of treatment. The study will measure whether the capsaicin patch or duloxetine is more effective at reducing pain intensity by at least 30%.
Treatments being tested: The capsaicin patch contains a natural compound from chili peppers that reduces pain signals. Duloxetine is an oral medication that increases brain chemicals to help manage nerve pain. Both are being compared to see which works better for chemotherapy-related nerve damage.
Study on the Effectiveness of Ozone Therapy for Pain Relief in Cancer Patients with Chemotherapy-Induced Peripheral Neuropathy
This Spanish trial examines whether ozone therapy can relieve pain in cancer patients experiencing nerve damage from chemotherapy. The study is designed as a triple-blind trial, meaning neither patients, healthcare providers, nor researchers know who receives active treatment versus placebo.
Who can participate: Adults aged 18 or older with cancer at any stage who are receiving chemotherapy and have a life expectancy exceeding 6 months. Participants must have painful nerve damage from chemotherapy lasting more than 3 months with a pain level greater than 3 out of 10. Women of childbearing age must have a negative pregnancy test and use birth control during the study period.
Who cannot participate: Patients who have not experienced chemotherapy-related nerve pain for more than 3 months, those with pain below Grade 2 severity, and individuals not receiving standard management for their condition.
Main goal: To assess whether adding ozone therapy to standard care can reduce pain and improve quality of life in patients with chemotherapy-induced nerve damage. The study will also evaluate cost-effectiveness of this treatment approach.
Treatment being tested: Ozone therapy is administered rectally as a medicinal gas. The trial will monitor pain levels using questionnaires and also assess factors such as anxiety, depression, and nerve function through various tests including blood work and imaging.
Study of brimonidine tartrate gel to prevent nerve damage in breast cancer patients receiving taxane treatment
This French trial investigates whether a topical gel called TAR-0520, containing brimonidine tartrate, can prevent nerve damage in breast cancer patients receiving taxane chemotherapy.
Who can participate: Adults aged 18 or older with confirmed breast cancer who are scheduled to receive weekly infusions of paclitaxel or docetaxel. Participants must be able to understand and follow study procedures and willing to apply the gel twice daily to one hand and one foot.
Who cannot participate: People with allergic reactions to topical medications, open wounds or skin infections on hands or feet, severe skin conditions, pregnancy or breastfeeding, severe existing nerve damage requiring immediate treatment, or other neurological conditions that could affect study results.
Main goal: To verify the safety of TAR-0520 Gel when applied to the skin during chemotherapy treatment, extending up to 36 weeks. The study will monitor for side effects and evaluate whether the gel can prevent the numbness, tingling, and pain that commonly occur in hands and feet during taxane treatment.
Treatment being tested: TAR-0520 Gel is applied topically twice daily to one hand and one foot throughout the chemotherapy treatment period. The gel belongs to a class of medications called alpha 2 agonists and is designed to protect nerves from damage during cancer treatment.
Study on Psilocybin for Relieving Chronic Neuropathic Pain in Patients with Chemotherapy-Induced Peripheral Neuropathy
This Netherlands trial explores whether psilocybin, a substance derived from mushrooms, can help reduce chronic nerve pain in people who have undergone chemotherapy.
Who can participate: Adults aged 18 or older who have chronic nerve pain that started after chemotherapy, with the condition diagnosed at least 6 months prior. Participants must report an average pain level of at least 4 on a scale from 0 to 10 and have maintained stable pain medication for at least 2 weeks. They must be able to read, write, and understand Dutch and have someone available to accompany them home after treatment.
Who cannot participate: People currently using other experimental treatments, those with a history of severe mental health disorders like schizophrenia or bipolar disorder, patients with recent heart attacks or severe heart disease, those with uncontrolled high blood pressure, pregnant or breastfeeding individuals, and people with a history of substance abuse.
Main goal: To assess whether psilocybin can reduce how much pain interferes with daily activities. The study will also examine changes in emotional and psychological well-being and overall quality of life.
Treatment being tested: Psilocybin is administered orally in capsules at two different doses: 1 mg and 25 mg. The substance works by interacting with serotonin receptors in the brain, which may alter pain perception and mood. Oxazepam tablets are also provided as part of the study protocol.
Study Comparing Gadoquatrane with Gadoteric Acid, Gadoteridol, and Gadobutrol for MRI in Patients with Non-CNS Conditions
This multi-country trial, conducted in Czechia, Italy, Germany, Hungary, France, Poland, Sweden, and Bulgaria, evaluates a new MRI contrast agent called gadoquatrane.
Who can participate: Adults aged 18 or older who have a medical reason to undergo a contrast-enhanced MRI for any body region except the brain or spinal cord. This includes scans of the head and neck, chest, abdomen, pelvis, or limbs. Female participants must follow local contraception guidelines and not be pregnant or breastfeeding.
Who cannot participate: People allergic to gadoquatrane or similar substances, those with severe kidney problems, pregnant women, patients with certain heart conditions, those who recently had an MRI with a different contrast agent, children under 2 years old, and anyone unable to undergo an MRI scan.
Main goal: To determine if gadoquatrane is as effective and safe as currently approved contrast agents in producing clear MRI images. Participants will undergo two MRI scans: one with gadoquatrane and one with an approved agent.
Treatment being tested: Gadoquatrane is a gadolinium-based contrast agent administered through intravenous injection. It helps improve the clarity of MRI images by altering the magnetic properties of nearby water molecules. The study compares it with other approved agents including gadoteric acid, gadoteridol, and gadobutrol.
Study on the Effect of Botulinum Toxin Type A and Sodium Chloride for Patients with Chronic Neuropathic Pain
This Danish trial investigates whether Botox injections can relieve chronic nerve pain affecting the skin.
Who can participate: Adults aged 18 or older with painful skin areas showing altered sensations compared to the opposite side of the body. These sensations may include reduced feeling for touch, cold, heat, or pinprick, or increased pain from normally non-painful stimuli. Participants must have undergone a nerve block at the Nerve Injury Clinic within the last 28 days that reduced pain to 3 or below on a pain scale. The pain must have persisted for at least 6 months with a score of 5 or higher. Participants must be able to read and understand Danish.
Who cannot participate: People not experiencing chronic nerve pain affecting the skin, those outside the specified age range, and members of vulnerable populations.
Main goal: To investigate whether Botox can provide pain relief when injected near affected nerves. The study will monitor pain levels, sleep quality, activity levels, and overall satisfaction with treatment over time.
Treatment being tested: Botox is injected around nerves at a dosage of 50 Allergan units. The treatment works by blocking the release of neurotransmitters involved in pain signaling, potentially reducing pain perception. Results are evaluated 4 weeks after injection.
Study on the Effectiveness of Human Normal Immunoglobulin for Treating Painful Nerve Damage in Patients with Primary Sjögren’s Syndrome
This French trial tests whether Privigen, a solution containing human normal immunoglobulin, can treat painful nerve problems in people with Primary Sjögren’s Syndrome.
Who can participate: Adults aged 18 to 79 years with Primary Sjögren’s syndrome and nerve damage affecting sensation or both sensation and movement, confirmed by electromyography testing. Participants must have good kidney function with a clearance rate greater than 50 ml/min/1.73m². Viral testing for HIV and hepatitis is required, and effective contraception must be used during the study. Participants must be able to understand study information and provide written consent.
Who cannot participate: Patients with nerve damage clearly defined as pure sensory or sensorimotor neuropathy confirmed by electromyography testing and those meeting criteria for Primary Sjögren’s syndrome.
Main goal: To determine if intravenous immunoglobulins can effectively treat nerve damage associated with Primary Sjögren’s syndrome. The study aims to achieve at least 20% improvement over placebo in pain scales and functional assessments three weeks after the last treatment course.
Treatment being tested: Privigen is administered through intravenous infusion. The immunoglobulins are a mixture of antibodies intended to help modulate the immune system and reduce inflammation, potentially alleviating nerve pain and improving nerve function.
Study on the Effects of AT-007 for Patients Aged 16-55 with Sorbitol Dehydrogenase Deficiency
This trial, conducted in Czechia and Italy, studies AT-007 for a rare genetic condition called Sorbitol Dehydrogenase (SORD) Deficiency, which affects the body’s ability to process certain sugars.
Who can participate: Males and non-pregnant, non-breastfeeding females between ages 16 and 55 with a clinical diagnosis of CMT2 or dHMN due to SORD Deficiency. This must be confirmed by high sorbitol levels (more than 10,000 ng/mL) and genetic testing showing a specific mutation. Participants can be on other medications but must maintain stable doses for at least one month before and throughout the study. Females of childbearing age must use reliable birth control.
Who cannot participate: People outside the age range of 16 to 55 years, those without SORD Deficiency, patients unable to perform the 10-meter walk/run test, and members of vulnerable populations.
Main goal: To evaluate whether AT-007 can improve physical abilities, measured through a 10-meter walk/run test over 24 months. The study will also assess how the treatment affects blood sorbitol levels over 12 months and whether it can reduce the accumulation of this sugar in the body.
Treatment being tested: AT-007 is taken as an oral suspension. It works as an aldose reductase inhibitor, reducing the conversion of glucose to sorbitol and thereby decreasing sorbitol accumulation in the body. The 24-month study will monitor changes in muscle composition using MRI scans and gather feedback about how the disease and treatment affect daily life.
Summary
The 9 ongoing clinical trials for peripheral neuropathy demonstrate a diverse range of therapeutic approaches targeting different causes and manifestations of nerve damage. A notable concentration of trials is evident in France, which hosts 4 studies, followed by Spain with 2 trials focusing specifically on ozone therapy. The remaining trials are distributed across multiple European countries, with one multi-country study spanning 8 nations.
Chemotherapy-induced peripheral neuropathy is the most frequently studied condition, addressed in 5 of the 9 trials, reflecting the significant unmet medical need in this patient population. Treatment approaches vary considerably, ranging from topical applications like capsaicin patches and brimonidine gel to systemic therapies including duloxetine, psilocybin, and immunoglobulins. Two Spanish trials are investigating ozone therapy, representing an alternative treatment approach that warrants further evidence.
The trials also address less common causes of nerve damage, including autoimmune conditions like Primary Sjögren’s Syndrome and rare genetic disorders such as SORD Deficiency. One large multi-country study focuses on improving MRI imaging for diagnosis rather than treatment. The diversity of treatment modalities reflects the complexity of managing peripheral neuropathy and the ongoing search for effective interventions across different patient populations.
