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Study on the Effectiveness and Safety of AP707 with Lamotrigine and Amitriptyline for Patients with Chronic Central Neuropathic Pain

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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 evaluating the effectiveness and safety of a treatment called AP707 for individuals experiencing chronic pain due to central neuropathy. Central neuropathy is a condition where nerve damage in the central nervous system causes persistent pain. The study aims to determine how well AP707 works as an additional treatment for managing this type of pain.

Participants in the study will receive either the AP707 treatment or a placebo, which looks like the treatment but does not contain the active ingredient. The study will last for a total of 52 weeks, during which participants will be monitored at various intervals to assess changes in their pain levels and overall well-being. The treatment is administered as a sublingual spray, meaning it is sprayed under the tongue for absorption.

Throughout the study, participants' pain levels will be measured using a simple scale, and other aspects such as quality of life, sleep quality, and psychological well-being will also be evaluated. The goal is to see if AP707 can provide significant relief from chronic pain and improve the quality of life for those affected by central neuropathy.

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

    Beginning of the trial

    Upon joining the clinical trial, you will be introduced to the study's objectives and procedures. You will be asked to provide a signed and dated informed consent form, confirming your understanding and willingness to participate.

    You will be assessed to ensure you meet the inclusion criteria, such as having chronic pain due to central neuropathy for at least three months and a pain intensity of 5 or more on a scale from 0 to 10.

  2. Step 2

    Baseline assessment

    Before starting the treatment, a baseline assessment will be conducted. This includes completing questionnaires to evaluate your current pain levels, psychological distress, and quality of life.

    The Numeric Rating Scale (NRS) will be used to measure your pain intensity, and other questionnaires like the Neuropathic Pain Symptom Inventory (NPSI) and Depression Anxiety Stress Scales Short Form (DASS-21) will be administered.

  3. Step 3

    Treatment phase 1

    You will begin the first treatment phase, which lasts for 14 weeks. During this time, you will receive either the active treatment, AP707, or a placebo. The treatment is administered as a sublingual spray, which means it is sprayed under the tongue.

    Your pain levels and other health indicators will be monitored regularly. You will be asked to report any changes in your condition and any side effects you experience.

  4. Step 4

    Evaluation at week 14

    At the end of the first treatment phase, your pain levels will be reassessed using the NRS and other questionnaires. This evaluation will help determine the effectiveness of the treatment.

    You will continue to the next phase of the trial based on the results of this assessment.

  5. Step 5

    Treatment phase 2

    The second treatment phase lasts until week 26. You will continue receiving the same treatment as in the first phase, either AP707 or placebo.

    Regular monitoring and assessments will continue, focusing on changes in pain levels and overall health.

  6. Step 6

    Evaluation at week 26

    Another evaluation will be conducted at the end of the second treatment phase. Your pain levels and other health indicators will be reassessed.

    The results will be compared to previous assessments to track any improvements or changes.

  7. Step 7

    Treatment phase 3

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

    Ongoing assessments will be conducted to monitor your condition and any side effects.

  8. Step 8

    Final evaluation at week 52

    At the end of the trial, a comprehensive evaluation will be conducted. This includes reassessing your pain levels, psychological distress, and quality of life.

    The data collected throughout the trial will be analyzed to determine the overall efficacy and tolerability of the treatment.

Who can join the trial?

9 criteria

  • Signed and dated informed consent form.
  • Patients with chronic pain due to central neuropathy for at least 3 months. Central neuropathy refers to nerve damage in the central nervous system, which includes the brain and spinal cord.
  • 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 has been adjusted to the best possible level.
  • Willingness to use reliable contraception during the study and for three months after the last dose of 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 a Numeric Rating Scale (NRS), which is a scale from 0 to 10 used to measure pain levels.
  • Completed QUISS questionnaire with a score of 45 or less. The QUISS is a questionnaire used to assess certain symptoms.

Who cannot join the trial?

3 criteria

  • Patients who have a different type of pain that is not caused by central neuropathy cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, 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 damage to the central nervous system, which includes the brain and spinal cord. The goal of using AP707 in this trial is to help reduce the pain that patients experience due to this kind of nerve damage. The trial is focused on understanding if AP707 can effectively help manage this pain and improve the quality of life for patients who suffer from it.

What is already known about the treatment

AP707 – AP707 is administered as an add-on treatment for chronic pain caused by central neuropathy, which can arise from various origins. Currently, AP707 is being studied in clinical trials to assess its effectiveness and safety for this specific type of pain. The medication works by targeting specific pathways in the nervous system to help reduce pain signals, although the exact molecular mechanism is still under investigation. AP707 falls under the pharmacological classification of pain management therapies, specifically focusing on neuropathic pain relief.

Investigated diseases

Central Neuropathic Pain – Central neuropathic pain is a type of chronic pain that arises from damage or dysfunction in the central nervous system, which includes the brain and spinal cord. This condition can result from various causes, such as stroke, multiple sclerosis, or spinal cord injury. The pain is often described as burning, shooting, or stabbing and can be persistent or intermittent. It may be accompanied by other symptoms like tingling, numbness, or a sensation of pins and needles. Over time, the pain can become more intense and may spread to other areas of the body. The progression of central neuropathic pain can vary greatly among individuals, depending on the underlying cause and the extent of nerve damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500899-66-00Protocol codeDISCOVER_(ZNP)Estimated enrolment558 patientsSponsorApurano Pharmaceuticals GmbH

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