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Adezunap

Clinical trials are investigating Adezunap in different patient groups. The studies look at whether it can help with several types of chronic pain and with borderline personality disorder, while also checking safety and tolerability. Most pain studies are Phase 3 trials, and one mental health study is Phase 2.

Table of Contents

Trial overview

The clinical trials of Adezunap studied two main areas: chronic pain and borderline personality disorder.[1][2][3][4][5] Four trials were Phase 3 and one trial was Phase 2.[1][2][3][4][5] The pain studies were completed, while the borderline personality disorder study was authorised.[1][2][3][4][5]

Pain studies in Phase 3

Three Phase 3 trials tested Adezunap as an add-on treatment for different types of chronic pain.[1][2][3][4] The conditions were chronic pain due to traumatic or post-operative peripheral neuropathy, chronic back pain, chronic pain due to central neuropathy of any genesis, and chronic pain due to diabetic polyneuropathy.[1][2][3][4]

These studies all used the same main design features: interventional research, Phase 3, completed status, and 558 enrolled participants in each trial.[1][2][3][4] The trials compared the active treatment with placebo, which is a look-alike treatment without the active study drug.[1][2][3][4]

  • Traumatic or post-operative peripheral neuropathy: this means nerve pain after an injury or surgery, affecting nerves outside the brain and spinal cord.[1]

  • Chronic back pain: long-lasting pain in the back that did not go away during the study period.[2]

  • Central neuropathy of any genesis: nerve-related pain from the central nervous system, with any cause or origin.[3]

  • Diabetic polyneuropathy: nerve damage linked to diabetes that affects multiple nerves and can cause chronic pain.[4]

Borderline personality disorder study

One authorised Phase 2 trial is studying Adezunap in people with borderline personality disorder.[5] This study is interventional and includes 154 participants.[5] It compares Adezunap with placebo to see whether the treatment can help reduce symptoms.[5]

The study uses two symptom measures: the ZAN-BPD total score and the BSL-23 total score.[5] These are rating tools that help researchers track how borderline personality disorder symptoms change over time.[5]

What the trials measured

The main outcome in the pain studies was the change in pain level on the Numeric Rating Scale, or NRS, from baseline to treatment week 14.[1][2][3][4] Baseline means the starting point before treatment begins.[1][2][3][4] The NRS is a simple pain scale from 0 to 10, where higher numbers mean more pain.[1][2][3][4]

The borderline personality disorder study measures change from baseline to end of treatment in the ZAN-BPD and BSL-23 scores, adjusted for the starting score.[5] This means the researchers compare groups while taking into account where participants started before treatment.[5]

Who could participate

Each trial focused on a specific patient group, so participants needed to have the condition being studied.[1][2][3][4][5] The pain trials were for adults with a defined chronic pain diagnosis, and the psychiatric trial was for people with borderline personality disorder.[1][2][3][4][5]

The source data show that some pain studies included add-on treatment, which means the study treatment was used together with other pain medicines already in place.[1][2][3][4] The trial records also list several comparator medicines in the pain studies, including gabapentin, amitriptyline, imipramine, capsaicin, and other pain treatments, but the main comparison reported was Adezunap versus placebo.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
2022-500898-13-00 Phase 3 Chronic pain due to traumatic or post-operative peripheral neuropathy Completed 558
2022-502151-54-00 Phase 3 Chronic back pain Completed 558
2022-500899-66-00 Phase 3 Chronic pain due to central neuropathy of any genesis Completed 558
2022-500897-32-00 Phase 3 Chronic pain due to diabetic polyneuropathy Completed 558
2024-510873-11-00 Phase 2 Borderline personality disorder Authorised 154

FAQ

  • What conditions have been studied with Adezunap? The trials studied chronic pain due to traumatic or post-operative peripheral neuropathy, chronic back pain, chronic pain due to central neuropathy, chronic pain due to diabetic polyneuropathy, and borderline personality disorder.
  • What phases are the Adezunap trials in? Most of the pain studies are Phase 3 trials. The trial in borderline personality disorder is a Phase 2 study.
  • Who can take part in these studies? Each trial focused on a specific patient group. People had to have the condition being studied, such as a certain type of chronic pain or borderline personality disorder.
  • What are the trials trying to measure? The pain studies measured change in pain scores using the Numeric Rating Scale, which is a 0 to 10 pain scale. The borderline personality disorder study measured changes in ZAN-BPD and BSL-23 scores.
  • Are these studies completed? The four pain studies are completed. The borderline personality disorder study is authorised.

Ongoing Clinical Trials on Adezunap

  • A study to evaluate the effectiveness and safety of AP707 in patients with borderline personality disorder.

    Not yet recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effectiveness and Safety of AP707 and Naproxen for Patients with Chronic Back Pain

    Not recruiting

    3 1 1
    Investigated drugs:
    Austria Germany

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

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

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

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

  • Study on the Effectiveness and Safety of AP707, Amitriptyline, and Capsaicin for Patients with Chronic Pain from Diabetic Neuropathy

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

Glossary

  • Phase 2: An early study stage that looks mainly at whether a treatment may work and how safe it is in a smaller group of people.
  • Phase 3: A later study stage that compares treatments in larger groups to see how well they work and how well people tolerate them.
  • Interventional study: A study where researchers give a treatment to participants and then measure the results.
  • Placebo: A look-alike treatment with no active study drug. It is used for comparison.
  • Verum: The active study treatment being tested, compared with placebo.
  • Peripheral neuropathy: Nerve damage outside the brain and spinal cord, which can cause pain, tingling, or numbness.
  • Central neuropathy: Nerve-related pain linked to the central nervous system, which includes the brain and spinal cord.
  • Diabetic polyneuropathy: Nerve damage caused by diabetes that affects many nerves and can lead to chronic pain.
  • Numeric Rating Scale (NRS): A pain scale from 0 to 10, where 0 means no pain and 10 means the worst pain.
  • ZAN-BPD: A questionnaire used to measure symptoms of borderline personality disorder.
  • BSL-23: A 23-item scale used to measure borderline personality disorder symptoms.
  • End of treatment (EoT): The time point when treatment ends and results are checked.

References

  1. https://clinicaltrials.gov/study/2022-500898-13-00
  2. https://clinicaltrials.gov/study/2022-502151-54-00
  3. https://clinicaltrials.gov/study/2022-500899-66-00
  4. https://clinicaltrials.gov/study/2022-500897-32-00
  5. https://clinicaltrials.gov/study/2024-510873-11-00