Ongoing Clinical Trials for Neuralgia
This article provides information about 9 ongoing clinical trials investigating various treatments for neuralgia and related neuropathic pain conditions. These studies are testing medications including capsaicin patches, botulinum toxin, cannabis-based medicines, pregabalin, and other treatments across multiple European countries including France, the Netherlands, Portugal, Finland, Poland, Spain, Germany, Bulgaria, and Hungary.
Clinical trial locations
- Bulgaria
- Espagne
- Finland
- France
- Study Comparing Serratus Plane Block, Capsaicin, and Botulinum Toxin Type A for Chronic Pain in Post-Mastectomy Patients
- Study on Capsaicin Patch for Treating Chronic Neuropathic Pain in Children Aged 12-17
- Study on Capsaicin for Treating Post-Surgical Neuropathic Pain in Patients
- Study on the Effectiveness and Safety of NT 201 Injections for Adults with Chronic Neuropathic Pain from Postherpetic Neuralgia or Nerve Injury
- Germany
- Hungary
- Netherlands
- Study on the Effects of THC 2% Oil for Patients with Chronic Neuropathic Pain
- Study on Lacosamide and Duloxetine for Patients with Chemotherapy-Induced Neuropathic Pain
- Study on Psilocybin for Relieving Chronic Neuropathic Pain in Patients with Chemotherapy-Induced Peripheral Neuropathy
- Study on Capsaicin for Treating Post-Surgical Neuropathic Pain in Patients
- Poland
- Portugal
- Spain
Study Comparing Serratus Plane Block, Capsaicin, and Botulinum Toxin Type A for Chronic Pain in Post-Mastectomy Patients
This French trial is comparing three different treatments for chronic nerve pain that develops after breast cancer surgery. The study focuses on women aged 18 or older who have undergone mastectomy and continue experiencing moderate to severe pain despite trying standard treatments for at least four weeks.
Inclusion criteria: Participants must be women who have had breast cancer surgery with either complete or partial removal of the breast, along with lymph node procedures. The pain must be chronic, lasting between 3 and 9 months after surgery, with a moderate to severe intensity score of 3 or higher on a scale of 0 to 10. The painful area should be limited to a specific location at the surgical site, armpit, or inner arm on the same side as the surgery. Women must have tried first-line treatments such as medications like venlafaxine, gabapentin, or tricyclic antidepressants along with a lidocaine patch without adequate relief.
Exclusion criteria: Only women can participate in this study. Men are excluded, as are individuals outside the specified age range and those considered part of vulnerable populations requiring special protection.
Focus: The trial is evaluating three different approaches: Serratus Plane Block, an 8% capsaicin patch, and Botulinum toxin type A injections. The main assessment occurs 8 weeks after treatment begins, measuring pain levels on a numerical scale. Participants will be monitored for changes in pain, quality of life, and psychological well-being at multiple time points up to 24 weeks.
Investigational drugs: The trial tests three treatments. The Serratus Plane Block involves injecting local anesthetic near a specific muscle to block pain signals. The capsaicin patch uses an 8% concentration to desensitize pain receptors in the skin. Botulinum toxin type A works by blocking nerve signals that cause muscle contractions, which can help alleviate pain.
Study on Capsaicin Patch for Treating Chronic Neuropathic Pain in Children Aged 12-17
This French study is investigating whether a capsaicin patch called Qutenza can effectively treat nerve pain in children and adolescents aged 12 to 17 who experience persistent pain following surgery or injury.
Inclusion criteria: Young people between 12 and 17 years old, of either gender, who have persistent nerve pain for more than 32 months after surgery or injury are eligible. The pain must not have responded to recommended treatments and must have a DN4 score of 3 out of 7 or 4 out of 10 or higher. The pain location must correspond to the area affected by the surgery or injury. All treatment and monitoring must occur at a designated study center.
Exclusion criteria: Those outside the age range of 12 to 17 years cannot participate. Children without chronic post-surgical or post-traumatic nerve pain are excluded, as are those from vulnerable populations.
Focus: The trial will compare the capsaicin patch to a placebo over a four-month period. Pain symptoms will be assessed using the Neuropathic Pain Symptom Inventory, which scores pain from 0 to 100. The study will also evaluate daily functioning using the Functional Disability Inventory. Participants will have their pain levels recorded daily and will undergo regular check-ups and phone calls to monitor side effects and well-being.
Investigational drug: The Capsaicin 8% cutaneous patch contains a natural compound found in chili peppers. When applied to the skin, it reduces pain signals sent to the brain by affecting pain receptors, helping to lessen pain in the affected area.
Study on the Effects of THC 2% Oil for Patients with Chronic Neuropathic Pain
This Dutch trial is examining whether THC 2% oil, containing the cannabis compound dronabinol, can provide relief for people suffering from chronic nerve pain.
Inclusion criteria: Adults aged 18 or older who have experienced chronic nerve pain for at least 3 months with a pain score greater than 4 on a numeric rating scale are eligible. Participants must score at least 4 on the DN4 questionnaire used to identify nerve pain. They must be able to communicate in Dutch and be willing to follow study rules.
Exclusion criteria: Those without chronic nerve pain, individuals outside the age range, people not willing to follow study procedures, those with interfering medical conditions or medications, pregnant or breastfeeding women, people with substance abuse history, recent clinical trial participants, and those with allergies to the study medication are excluded.
Focus: Participants will receive either THC 2% oil or a placebo applied under the tongue. The study uses a crossover design, meaning participants will switch to the other treatment partway through. Regular assessments will monitor pain severity, sleep quality, anxiety, depression, and overall quality of life throughout the study period.
Investigational drug: THC 2% oil contains tetrahydrocannabinol, a compound from cannabis plants. It works by interacting with the body’s endocannabinoid system, which helps regulate pain and inflammation. The oil is applied under the tongue for absorption.
Study on the Effects of THC and CBD Oral Solution for Chronic Neuropathic Pain in Multiple Sclerosis Patients
This Portuguese study is testing an oral solution called Satalliv, which combines THC and CBD, for treating chronic nerve pain in people with multiple sclerosis.
Inclusion criteria: Native Portuguese speakers aged 18 to 65 who have been diagnosed with multiple sclerosis for more than 6 months are eligible. Participants must have had chronic nerve pain due to MS for at least 6 months and have tried at least one pain medication that did not work or was not tolerated. They must be on stable doses of disease-modifying therapies for at least 6 months and other medications for at least 4 weeks. Female participants must use effective birth control, and male participants must use condoms. Participants must be willing to avoid driving during the study.
Exclusion criteria: Those without chronic nerve pain due to MS, individuals outside the age range, pregnant or breastfeeding women, those unwilling to follow study procedures, people with interfering medical conditions, current clinical trial participants, and those with substance abuse history or medication allergies are excluded.
Focus: The study lasts 12 weeks, with the main focus on the first 4 weeks. Participants will be randomly assigned to receive either the THC/CBD solution containing 25 mg of each compound per milliliter or a placebo. Pain levels will be measured on a scale from 0 to 10 at baseline, 4 weeks, and 12 weeks. Regular assessments will monitor overall health, side effects, and changes in condition.
Investigational drug: The THC/CBD oral solution combines two cannabis compounds. THC provides relaxation effects, while CBD helps reduce pain and inflammation without causing a high. Together, they interact with the body’s endocannabinoid system to regulate pain and inflammation.
Study on Lacosamide and Duloxetine for Patients with Chemotherapy-Induced Neuropathic Pain
This Dutch trial is comparing two medications, lacosamide and duloxetine, to see which better manages nerve pain that develops after chemotherapy treatment.
Inclusion criteria: Adults over 18 years old who can provide consent are eligible. Participants must show signs of nerve damage through special tests, have a pain score of 4 or higher, and have received chemotherapy with specific drugs like taxanes, platinums, vicalkiniods, or bortezomib. Symptoms of nerve pain must have persisted for at least 3 months after completing chemotherapy.
Exclusion criteria: Those currently receiving other neuropathic pain treatments, individuals with allergic reactions to the test medications, people with severe liver or kidney problems, pregnant or breastfeeding women, recent clinical trial participants, those with certain mental health conditions, and people unable to follow study procedures are excluded.
Focus: The eight-week study randomly assigns participants to receive either lacosamide film-coated tablets or duloxetine gastro-resistant capsules. The primary focus is pain intensity during the last 4 weeks of treatment. Secondary outcomes include patient satisfaction and side effects monitoring.
Investigational drugs: Lacosamide works by stabilizing hyperexcitable neuronal membranes through selective enhancement of slow inactivation of voltage-gated sodium channels. Duloxetine inhibits the reuptake of serotonin and norepinephrine, neurotransmitters involved in mood and pain perception.
Study on Psilocybin for Relieving Chronic Neuropathic Pain in Patients with Chemotherapy-Induced Peripheral Neuropathy
This Dutch study is exploring whether psilocybin, a compound derived from certain mushrooms, can help manage chronic nerve pain that persists after chemotherapy treatment.
Inclusion criteria: Adults at least 18 years old with chronic nerve pain that began after chemotherapy are eligible. Participants must be at least six months past diagnosis of chemotherapy-induced peripheral neuropathy confirmed by a doctor. Average pain levels must be at least 4 on a 0 to 10 scale in the week before assessment. Pain treatment must have been stable for at least two weeks. Participants must read, write, and understand Dutch, and must have someone to accompany them home after treatment.
Exclusion criteria: Those using other experimental drugs, individuals with severe mental health disorders like schizophrenia or bipolar disorder, people with recent heart attacks or severe heart disease, those with uncontrolled high blood pressure, pregnant or breastfeeding women, people with substance abuse history, those unable to provide informed consent, recent clinical trial participants, and people with conditions making participation unsafe are excluded.
Focus: The study will assess whether psilocybin can reduce pain interference with daily activities. Participants will receive psilocybin capsules in two doses (1 mg and 25 mg) or a placebo, along with oxazepam tablets. All medications are taken orally. The study will monitor pain levels, emotional state, and quality of life throughout the trial period.
Investigational drug: Psilocybin is administered orally in capsule form. It works by interacting with serotonin receptors in the brain, which can alter perception and mood, potentially reducing pain sensation.
Study on the Effect of Pregabalin on Sleep and Pain in Patients with Neuropathic Pain
This Finnish trial is investigating how pregabalin affects both pain levels and sleep patterns in people with peripheral nerve pain.
Inclusion criteria: Men and women between 18 and 75 years old with peripheral nerve pain are eligible. The pain must be chronic, lasting more than 3 months, and of moderate to severe intensity with a score of 4 or higher on a 0 to 10 scale. Participants should have either moderate sleep disturbance with an ISI-questionnaire score greater than 14, or no sleep disturbance at all.
Exclusion criteria: Those without persistent peripheral nerve pain, individuals outside the age range, and people belonging to vulnerable populations are excluded.
Focus: The study analyzes sleep structure in detail using overnight sleep studies and devices like the OURA-ring and iButton to track sleep patterns and body temperature. Participants will receive pregabalin in hard capsules at doses of 25 mg, 75 mg, or 150 mg taken orally. The trial will monitor pain intensity using numeric rating scales and assess quality of life, anxiety, and depression at baseline, 8 weeks, and 24 weeks. Brain fMRI scans will study connections between sleep disturbances and brain network connectivity.
Investigational drug: Pregabalin works by binding to calcium channels in the nervous system, reducing the release of neurotransmitters involved in pain transmission. It helps calm nerves and reduce pain signals in the brain, which may also improve sleep quality.
Study on Capsaicin for Treating Post-Surgical Neuropathic Pain in Patients
This multi-country study across Poland, Spain, France, and the Netherlands is testing whether the Qutenza capsaicin patch can effectively reduce nerve pain that develops after surgery.
Inclusion criteria: Adults aged 18 or older of any gender who have given written consent are eligible. Participants must have confirmed post-surgical nerve pain lasting between 6 to 60 months, related to surgery and extending beyond the scar area, with pain linked to sensory changes or direct surgical evidence of nerve damage. Average pain must be at least 4 out of 10 based on daily ratings over a week. The painful skin area should not exceed 1120 cm2, and the skin must be intact, dry, and not irritated. Participants must agree to follow restrictions on other treatments during the study.
Exclusion criteria: Those with non-surgical pain, current clinical trial participants, people with capsaicin allergies, those with interfering skin conditions, pregnant or breastfeeding women, people with conditions making participation unsafe, and those unable to follow study procedures are excluded.
Focus: The trial compares the Qutenza patch containing 179 mg of capsaicin to a low-dose capsaicin control. The main goal is observing changes in pain intensity from baseline to Week 12, with additional assessments up to Week 42. Participants will record daily pain levels using an electronic diary and attend regular follow-up visits to monitor progress and side effects.
Investigational drug: Qutenza is a topical patch containing capsaicin, a natural compound from chili peppers. It reduces pain by decreasing the sensitivity of pain receptors in the skin and reducing pain signals sent to the brain.
Study on the Effectiveness and Safety of NT 201 Injections for Adults with Chronic Neuropathic Pain from Postherpetic Neuralgia or Nerve Injury
This large multi-country trial across Poland, Spain, Germany, France, Bulgaria, and Hungary is studying NT 201, a form of Clostridium botulinum neurotoxin type A, for treating chronic nerve pain from either shingles or nerve injuries.
Inclusion criteria: Both men and women are eligible, including those from vulnerable populations. Participants must have chronic peripheral nerve pain lasting at least 6 months related to either past shingles or peripheral nerve injury from surgery or accident. They must have a documented diagnosis that is at least probably certain according to expert grading systems and must score at least 4 out of 10 on the DN4 questionnaire.
Exclusion criteria: Those with chronic pain unrelated to postherpetic neuralgia or peripheral nerve injury, people with allergic reactions to the study medication, current clinical trial participants, those with unsafe medical conditions, pregnant or breastfeeding women, people with recent substance abuse history, those who had major surgery within three months, and people with uncontrolled severe mental health conditions are excluded.
Focus: This double-blind study randomly assigns participants to receive either NT 201 injections under the skin or placebo injections. The trial monitors changes in pain levels over approximately 12 weeks, with regular follow-up visits every two weeks to assess effectiveness, safety, and side effects. Neither participants nor researchers know who receives the actual treatment until the study concludes.
Investigational drug: NT 201 is administered through subcutaneous injections. It targets specific pathways involved in pain signaling to reduce the intensity of daily pain experienced by patients with chronic nerve pain.
Summary
These nine clinical trials represent diverse approaches to managing different types of nerve pain. Several studies focus on capsaicin-based treatments, including the Qutenza patch, which is being tested in multiple countries and populations from children to adults. Cannabis-based medicines, including THC and CBD formulations, are being explored in the Netherlands and Portugal, reflecting growing interest in cannabinoid therapies for pain management.
Chemotherapy-induced nerve pain is a significant focus, with three separate trials investigating different treatment approaches including lacosamide, duloxetine, and psilocybin. Post-surgical pain conditions are addressed in multiple studies, including specific focus on post-mastectomy pain and general post-surgical nerve pain.
France appears prominently with involvement in four trials, while the Netherlands hosts three studies. This concentration suggests these countries are active centers for neuropathic pain research. The trials span various age groups, from adolescents as young as 12 to adults up to 75 years old, though most focus on adult populations.
The investigational treatments range from well-established medications like pregabalin and duloxetine to more novel approaches such as psilocybin and cannabis-based formulations. Many studies use comparison designs, either testing against placebos or comparing different active treatments to establish relative effectiveness. The duration of most trials ranges from several weeks to several months, with follow-up periods extending to monitor longer-term effects and safety.
