The trial will compare Qutenza(R) (8% capsaicin patch) to pregabalin as a treatment for peripheral neuropathic pain.
Pregabalin is an oral therapy used to treat peripheral neuropathic pain.
Finland Helsinki University Central Hospital pain management consultant and the ELEVATE study lead investigator associate professor Maija Haanpaa said it is important to perform head-to-head comparative studies, such as the Elevate study, in the field of neuropathic pain.
”The ELEVATE study may also provide information about the symptom profiles that are most likely to respond to the different treatments since the NPSI questionnaire, given during the trial, will be used to assess the characteristics of pain and other sensory symptoms," Haanpaa added.
The study will enroll 526 patients from approximately 100 centers in 23 countries across eastern and western Europe, including the UK, Germany, France, Italy, Spain, Sweden, Finland, Russia, Romania and Bulgaria.
The results of the Elevate study designed to know the efficacy and safety of the Qutenza topical patch against pregabalin are expected in 2014.
The Qutenza patch is designed to act on the affected area and has not shown side effects such as sedation and dizziness that may be experienced with other treatments.
Qutenza has been approved in the US for the management of neuropathic pain associated with post herpetic neuralgia (PHN).