Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy

Summary

The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.

Timeline

Start

2010-04

Primary completion

2012-05

Completion

2012-05

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description.”

paper At endpoint, the change from baseline in least-squares mean NRS pain scores in the intent-to-treat population was -2.04 for pregabalin versus -2.11 for placebo (P=.709). PMID 24907403 ↗

paper Overall, this trial did not show pregabalin to be more efficacious than placebo in treating HIV-associated DSP. PMID 24907403 ↗

Publications

• Simpson DM, Rice AS, Emir B, Landen J, Semel D, Chew ML, Sporn J. A randomized, double-blind, placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy. Pain. 2014 Oct;155(10):1943-54. doi: 10.1016/j.pain.2014.05.027. Epub 2014 Jun 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	75 mg	—
Subject	Pregabalin	Small molecule	300 mg	—

Indications