Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica

Phase 4 Completed 32 enrolled Depomed

RandomizedCrossoverOther

Summary

Phase 4, double-blind, placebo-controlled, four treatment, four sequence crossover study comparing simulated driving performance, daytime sedation and cognition in healthy volunteers administered therapeutic doses of Gralise® (Treatment A), Neurontin® (Treatment B), Lyrica® (Treatment C) and placebo (Treatment D). All doses were administered under fed conditions.

Timeline

Start: 2015-09-24
Primary completion: 2015-11-20
Completion: 2015-11-20

Publications

Schmidt P, Rao S. Effects of gabapentin, pregabalin and gastroretentive gabapentin on simulated driving, daytime sedation and cognition. Pain Manag. 2018 Jul 1;8(4):297-306. doi: 10.2217/pmt-2018-0005. Epub 2018 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Gabapentin	Small molecule	600 mg	—
Comparator	Gabapentin	Small molecule	1800 mg	—
Comparator	Pregabalin	Small molecule	150 mg	—

Indications

No indication recorded.