Electrophysiological Effects of ABT-639 on Diabetic Neuropathy

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Electrophysiology Effects of ABT-639 on Spontaneous Activity in C-Nociceptors in Patients with Diabetic Peripheral Neuropathy

• IRAS ID

  95536

• Contact name

  Jordi Serra

• Sponsor organisation

  Abbott Laboratories Limited (Abbott)

• Eudract number

  2011-005127-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  We are conducting a clinical trial at our research centre for patients suffering from diabetic peripheral neuropathy. We want to test a potential new medicine known as ABT-639 to dampen neuropathic pain which occurs with diseases such as diabetic peripheral neuropathy. Patients suffering from diabetic peripheral neuropathy, may be aware that the current drugs on the market are not always effective in treating pain and may have undesirable side-effects. ABT-639 works in a different way to current marketed drugs and for this reason it may work better and have fewer side effects compared to the current drugs. Therefore in this study we will collect information on peripheral (links the brain and spinal cord to the limbs) nerve activity using a technique known as ??microneurography?? which will help us to determine how well ABT-639 is working. We will compare the effect of ABT-639 with lidocaine, which is a local anaesthetic infused directly into a vein, and is also used to treat neuropathic pain as it has an effect on nerve fibres which block pain so it will be used as a comparator. We will also be testing the safety and tolerability of ABT-639. The study will last for approximately 35 days including the time when we determine who is suitable for taking part in the study, and the telephone follow-up at the end of the study. Patients who receive ABT-639 or lidocaine may experience reduced pain. Volunteers will be compensated for their time.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  12/SC/0038

• Date of REC Opinion

  7 Feb 2012

• REC opinion

  Further Information Favourable Opinion