Gabapentin and Donepezil Combination on Experimental Human Pain Models

Phase 1 Completed 48 enrolled GlaxoSmithKline

RandomizedCrossoverDouble-blindBasic science

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.

Timeline

Start: 2011-10-11
Primary completion: 2012-07-03
Completion: 2012-07-03

Outcome

Mixed primary results

paper Co-primary endpoints were the area of pinprick hyperalgesia (260 mN von Frey filament) and allodynia (stroking by cotton bud) PMID 25218827 ↗

paper Gabapentin+donepezil (n=30) significantly reduced the area of hyperalgesia vs gabapentin 900 mg (n=30; -11.73 cm(2); 95% CI -21.04 to -2.42; P=0.014) PMID 25218827 ↗

paper with supportive results for allodynia (-6.62 cm(2); 95% CI -13.29-0.04; P=0.052) PMID 25218827 ↗

Publications

Boyle Y, Fernando D, Kurz H, Miller SR, Zucchetto M, Storey J. The effect of a combination of gabapentin and donepezil in an experimental pain model in healthy volunteers: Results of a randomized controlled trial. Pain. 2014 Dec;155(12):2510-2516. doi: 10.1016/j.pain.2014.09.003. Epub 2014 Sep 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Donepezil	Small molecule	5 mg	Oral
Subject	Gabapentin	Unknown	900 mg	Oral
Subject	Gabapentin	Unknown	1800 mg	Oral