Clinical Trial: Pregabalin in the Treatment of Essential Tremor

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 17 Week, Investigator-initiated, Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Trial of Pregabalin in Essential Tremor

Brief Summary:

Pregabalin is approved for the treatment of nerve pain as well as an additional therapy in the treatment of seizures. In December 2004, Pfizer gained Food and Drug Administration (FDA) approval for use of pregabalin in nerve pain associated with diabetes and shingles; making it the first FDA-approved treatment for both of these nerve pain states.

Tremor is uncontrolled trembling in part of the body. Essential tremor (ET) is associated with purposeful movement(e.g., holding a glass to drink, shaving, writing and buttoning a shirt). It occurs most often in the hands and head and also may affect the arms, voice box (larynx), trunk, and legs. ET is caused by abnormalities in areas of the brain that control movement. It usually does not result in serious complications.

ET affects approximately 5 million people in the United States. Incidence is highest in people over the age of 60.

ET usually develops gradually during middle age or later in life. Symptoms may remain mild or become more severe over time. Stress, fatigue, anxiety, and hot or cold weather can worsen the disorder. Severe tremor may cause difficulty doing activities of daily living, such as:

  • Brushing hair and teeth
  • Holding a glass without spilling
  • Performing self-care (e.g., getting dressed, shaving, putting on makeup)
  • Using eating utensils
  • Writing and drawing

The purpose of this study is to examine the tolerability and efficacy of Pregabalin in patients with ET .

In other words, can patients d

Detailed Summary:
Sponsor: Baylor College of Medicine

Current Primary Outcome: Change from baseline in the overall TRS score obtained at the final evaluation (end of study). The overall TRS score will be derived from the three TRS subcecals giving a maximum score of 84 which will be converted to a 100 point scale. [ Time Frame: baseline to completion ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Nonparametric tests will be employed and exact p (2 tailed) values computed for the categorical dependent variables. [ Time Frame: baseline to completion ]

Original Secondary Outcome: Same as current

Information By: Baylor College of Medicine

Dates:
Date Received: December 28, 2007
Date Started: June 2006
Date Completion:
Last Updated: November 4, 2015
Last Verified: November 2015