In short
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.
Key points
- Clinical trials investigating Adezunap focus on two main areas: chronic pain and borderline personality disorder. Four Phase 3 studies looked at different types of chronic pain, including peripheral neuropathy, back pain, central neuropathy, and diabetic polyneuropathy. These pain trials were completed and each enrolled 558 participants. One Phase 2 study is authorised for borderline personality disorder and includes 154 participants. The main pain outcome was change in pain score on the Numeric Rating Scale, while the mental health study measures changes in ZAN-BPD and BSL-23 scores.
Trial overview
The clinical trials of Adezunap studied two main areas: chronic pain and borderline personality disorder. Four trials were Phase 3 and one trial was Phase 2. The pain studies were completed, while the borderline personality disorder study was authorised.
Pain studies in Phase 3
Three Phase 3 trials tested Adezunap as an add-on treatment for different types of chronic pain. 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.
These studies all used the same main design features: interventional research, Phase 3, completed status, and 558 enrolled participants in each trial. The trials compared the active treatment with placebo, which is a look-alike treatment without the active study drug.
- Traumatic or post-operative peripheral neuropathy: this means nerve pain after an injury or surgery, affecting nerves outside the brain and spinal cord.
- Chronic back pain: long-lasting pain in the back that did not go away during the study period.
- Central neuropathy of any genesis: nerve-related pain from the central nervous system, with any cause or origin.
- Diabetic polyneuropathy: nerve damage linked to diabetes that affects multiple nerves and can cause chronic pain.
Borderline personality disorder study
One authorised Phase 2 trial is studying Adezunap in people with borderline personality disorder. This study is interventional and includes 154 participants. It compares Adezunap with placebo to see whether the treatment can help reduce symptoms.
The study uses two symptom measures: the ZAN-BPD total score and the BSL-23 total score. These are rating tools that help researchers track how borderline personality disorder symptoms change over time.
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. Baseline means the starting point before treatment begins. The NRS is a simple pain scale from 0 to 10, where higher numbers mean more pain.
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. This means the researchers compare groups while taking into account where participants started before treatment.
Who could participate
Each trial focused on a specific patient group, so participants needed to have the condition being studied. The pain trials were for adults with a defined chronic pain diagnosis, and the psychiatric trial was for people with borderline personality disorder.
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. 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.