Completed Research Studies

8. Title: A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Trial of Pregabalin for the Treatment of Chronic Central Neuropathic Pain after Spinal Cord Injury

Purpose: The main purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury. This study aims to repeat the data on the effectiveness of pregabalin that was shown in the previous study. In addition, this study will also evaluate any side effects and whether or not they might be related to pregabalin. Lastly, this study will also assess whether subjects will experience improvement in sleep, general health, and on symptoms of anxiety and depression.

Principal Investigator: Ralph J. Marino, MD
Co-Investigator(s): Christopher S. Formal, MD

Background: Pregabalin is approved in the United States for the treatment of nerve pain related to diabetes and shingles, for partial seizures in adults, and for the management of fibromyalgia. Pregabalin is also approved in the European Union for the treatment of nerve pain and seizures in adults.

Pregabalin is not approved in the United States for the treatment of nerve pain related to spinal cord injuries. Therefore, its use in this study is investigational.

Numerous studies using pregabalin have been conducted by Pfizer involving over 13,000 subjects with a variety of conditions, including nerve pain. The results of these studies show pregabalin is generally effective and well-tolerated in the treatment of nerve pain associated with diabetes and herpes zoster (shingles). Currently, one research study has shown pregabalin to be effective in reducing nerve pain after spinal cord injury.

Study Dates: November 1, 2008 - September 7, 2010

Status: Study Completed

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