Protocol KF6010/01, version 3.0

• Research type

  Research Study

• Full title

  Evaluation of the efficacy, tolerability, and safety of 7 days of treatment with GRT6010 or pregabalin in comparison to placebo in subjects with peripheral neuropathic pain.

• IRAS ID

  85752

• Contact name

  Michael Serpell

• Sponsor organisation

  Grünenthal GmbH

• Eudract number

  2011-002092-42

• Research summary

  This clinical research study involves a novel peripherally acting analgesic compound called GRT6010 that is expected to be effective in peripheral neuropathic pain. Neuropathic pain may result from damage or disorders of the peripheral nervous system. It is associated with abnormal sensations and pain and may occur continuously and/or at irregular intervals. Some people may experience "pins and needles" tingling and pricking sensations, numbness, itching, burning or coldness. Neuropathic pain can be very difficult to treat, often patients only achieve partial relief. GRT6010 demonstrated in non-clinical models of chronic neuropathic pain the ability to counteract the effects of hyperalgesia (an abnormally heightened sensitivity to pain) and allodynia (pain from a stimulus that does not normally lead to the sensation of pain). Therefore, the aim of the trial is to evaluate the efficacy, tolerability, and safety of GRT6010 in subjects with peripheral neuropathic pain. Pre-clinical animal studies have clearly defined GRT6010 doses that are efficacious in neuropathic pain and those that cause side effects. If these findings are confirmed in man, it may result in GRT6010 having a very attractive tolerability and safety profile at doses providing relief from neuropathic pain. The trial will be conducted at about 20 European sites and 90 subjects between the ages of 18 and 65 are planned to be enrolled in the study. Subjects will be hospitalised and regularly monitored to guarantee Subjects?? safety. Any changes in vitals signs, ECG parameters and laboratory values will be observed and recorded. Eligible Subjects fulfiling the inclusion/exclusion criteria will only be enrolled once written signed and dated informed consent has been obtained.

• REC name

  Scotland A REC

• REC reference

  11/SS/0063

• Date of REC Opinion

  30 Nov 2011

• REC opinion

  Further Information Favourable Opinion