NCT01485185

Gabapentin and Donepezil Combination on Experimental Human Pain Models

A Randomized, Double Blind, Placebo Controlled Study to Investigate the Effect of Donepezil and Gabapentin Combination on an Experimental Pain Model in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will compare the effects of gabapentin alone, and gabapentin + donepezil given together in two types of experimental electrical pain tests in up to 48 healthy male subjects (after 24 recruited in the first cohort an interim analysis will be performed). The study is a randomized, double blind, placebo controlled, 3 was cross-over design study with incomplete block design and 4 treatment options. Placebo, gabapentin alone (lower dose and higher dose) or gabapentin (lower dose) with donepezil.

Detailed description

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 followup visit. Each treatment session consists of 12 days of dosing at home and 2 inpatient 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.

Conditions

• Pain, Neuropathic

Interventions

Type	Name	Description
DRUG	Gabapentin lower dose	Repeat, oral dose
DRUG	Donepezil	Repeat, oral dose
OTHER	Placebo (Dop)	Placebo to donepezil, Repeat, oral dose
OTHER	Placebo (Gaba)	Placebo to gabapentin, Repeat, oral dose
DRUG	Gabapentin higher dose	Repeat, oral dose

Timeline

• Start date: 2011-10-11
• Primary completion: 2012-07-03
• Completion: 2012-07-03
• First posted: 2011-12-05
• Last updated: 2017-06-12

Locations

1 site across 1 country: United Kingdom