gabapentin and donepezil combination on experimental human pain models

• Research type

  Research Study

• Full title

  A randomized, double blind, placebo controlled study to investigate the effect of donepezil and gabapentin combination on an experimental pain model in healthy subjects

• IRAS ID

  88430

• Contact name

  Disala Fernando

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2011-003655-19

• Research summary

  This study will compare the effects of gabapentin alone, and gabapentin donepezil given together in two types of experimental electrical pain tests which will be conducted on the forearm and the lower leg, in 24 healthy male subjects initially. Gabapentin (a drug for treatment of seizure disorders) is one of the drugs being used for the treatment of pain caused by the damage to the nerves. Donepezil is a treatment to improve memory in patients with Alzheimer??s disease. 24 more subjects may be recruited following a formal analysis during the trial (called interim analysis), if required for optimal scientific value. The study consists of 1 screening visit,1 visit to establish the baseline pain recordings before any treatment is given, then 3 treatment sessions, followed by a follow-up visit. Each treatment session consists of 12 days of dosing at home and 2 in-patient days for dosing and pain tests. Each volunteer takes part in 3 treatment sessions. In total, the study will last 15 weeks for each volunteer. There will be 4 treatment options: placebo, higher dose of gabapentin, low dose of gabapentin, low dose of gabapentin donepezil. All subjects will receive the last two options and one out of the first two options, in a random order selected by a computer before the study starts; neither the volunteers nor the persons conducting the pain assessments nor the study team will know which treatment the volunteers receive during the visits (known as a randomised, double-blind study). The study will be conducted in a specialist clinical research unit with adequate facilities with regard to safety and compliance. The results of the tests in the study will help to understand the effects of gabapentin and donepezil together to design future clinical trials.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0145

• Date of REC Opinion

  6 Oct 2011

• REC opinion

  Further Information Favourable Opinion