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Study on the Effectiveness of AP707, Gabapentin, and Capsaicin for Patients with Chronic Pain from Traumatic or Post-Operative Peripheral Neuropathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a treatment called AP707 for individuals experiencing chronic pain due to nerve damage from injuries or surgeries. Chronic pain is a long-lasting pain that persists for months or even years, often affecting daily life and activities. The treatment being tested, AP707, is a special spray used under the tongue, which contains an active ingredient called Adezunap. This study aims to see if AP707 can help reduce pain when used alongside other pain medications.

Participants in the study will be divided into two groups. One group will receive the AP707 treatment, while the other group will receive a placebo, which looks and smells like the real treatment but does not contain the active ingredient. The study will last for about a year, during which participants will have regular check-ups to monitor their pain levels and overall health. The goal is to determine if AP707 can effectively reduce pain and improve the quality of life for those suffering from chronic pain due to nerve damage.

Throughout the study, participants will continue to use their regular pain medications, which may include drugs like Gabapentin, Capsaicin, Imipramine, Amitriptyline, and Paracetamol. These medications are commonly used to manage pain and will be optimized for each participant. The study will also assess any changes in psychological well-being, sleep quality, and overall life satisfaction. By the end of the study, researchers hope to gather valuable information on the potential benefits of AP707 for managing chronic pain.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to evaluate your current health status and pain levels. This involves completing questionnaires and undergoing a physical examination.

    You will be asked to rate your pain using a scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain.

  2. Step 2

    Randomized treatment assignment

    You will be randomly assigned to one of two groups: one receiving the active treatment, AP707, and the other receiving a placebo. The placebo looks and smells like the active treatment but does not contain the active ingredient.

    This process ensures that the effects of the treatment can be accurately measured.

  3. Step 3

    Treatment phase 1

    During the first treatment phase, you will use the assigned treatment for 14 weeks. The treatment involves using a pump spray for sublingual application, which means spraying it under your tongue.

    You will continue to rate your pain levels regularly and complete additional questionnaires to monitor any changes in your symptoms.

  4. Step 4

    Evaluation at week 14

    At the end of week 14, your pain levels and overall health will be evaluated. This includes completing the same pain scale and questionnaires as before.

    The results will help determine the effectiveness of the treatment during the first phase.

  5. Step 5

    Treatment phase 2

    The second treatment phase lasts until week 26. You will continue using the assigned treatment and monitoring your pain levels.

    Regular check-ins and assessments will be conducted to track your progress and any side effects.

  6. Step 6

    Evaluation at week 26

    At the end of week 26, another evaluation will take place to assess changes in your pain and overall condition.

    This evaluation will help understand the long-term effects of the treatment.

  7. Step 7

    Treatment phase 3

    The final treatment phase extends to week 52. You will continue with the same treatment regimen and regular assessments.

    Your feedback and health status will be crucial in determining the treatment's efficacy over an extended period.

  8. Step 8

    Final evaluation at week 52

    At the end of the study, a comprehensive evaluation will be conducted to measure the overall impact of the treatment on your pain and quality of life.

    This final assessment will include all previous measures and additional questions about your experience during the trial.

Who can join the trial?

9 criteria

  • Signed and dated informed consent form.
  • Patients with chronic pain due to traumatic or post-operative peripheral neuropathy for at least 3 months. Peripheral neuropathy is a condition where nerves outside the brain and spinal cord are damaged, often causing pain.
  • Female and male patients who are 18 years or older.
  • Patients with a life expectancy of more than 1 year.
  • Patients with optimized sCPT at the start of the study. sCPT refers to a specific treatment plan that is adjusted to the patient's needs.
  • Willingness of both male and female patients to use reliable contraception during the study and for three months after taking the last study medication.
  • Good command of the German language to understand questionnaires in German.
  • Current moderate to severe pain with a pain intensity of 5 or more on the Numeric Rating Scale (NRS), which is a scale from 0 to 10 used to measure pain levels. This indicates a need for further pain therapy.
  • Completed QUISS (Quantification Inventory for Somatoform Syndromes) questionnaire with a score of 45 or less. This questionnaire helps assess certain symptoms related to pain.

Who cannot join the trial?

8 criteria

  • Patients with any other type of chronic pain not related to traumatic or post-operative peripheral neuropathy cannot participate. Peripheral neuropathy is a condition where nerves outside the brain and spinal cord are damaged, often causing weakness, numbness, and pain, usually in the hands and feet.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give informed consent, cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients with a history of substance abuse or addiction cannot participate.
  • Patients with severe mental health disorders that could interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with any medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.
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Investigated drugs

AP707 is a medication being tested to see how well it works and how well people can tolerate it when used as an additional treatment for chronic pain. This type of pain is caused by nerve damage that happens after an injury or surgery. The goal of using AP707 is to help reduce the pain that patients feel in these situations. The trial is focused on understanding if adding AP707 to the current treatment can make a difference in managing this kind of pain.

What is already known about the treatment

AP707 – AP707 is administered as an add-on treatment for chronic pain resulting from traumatic or post-operative peripheral neuropathy. Currently, it is being evaluated in clinical trials to determine its effectiveness and tolerability for this specific type of pain. The main therapeutic indication for AP707 is to alleviate chronic pain associated with nerve damage following trauma or surgery. At the molecular level, AP707 works by modulating nerve signals to reduce pain perception, although the exact mechanism is still under investigation. It falls under the pharmacological classification of pain management medications, specifically targeting neuropathic pain.

Investigated diseases

Chronic Pain due to Traumatic or Post-operative Peripheral Neuropathy – This condition involves persistent pain resulting from damage to peripheral nerves, which can occur after an injury or surgery. The pain is often described as burning, tingling, or shooting, and it can vary in intensity. Over time, the affected area may become hypersensitive, causing even light touches to be painful. The progression of this condition can lead to changes in the nervous system, which may amplify the pain signals. As the condition persists, it can interfere with daily activities and reduce the quality of life. The pain may also be accompanied by other symptoms such as numbness or weakness in the affected area.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500898-13-00Protocol codeDISCOVER_(PNP2)Estimated enrolment558 patientsSponsorApurano Pharmaceuticals GmbH

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