Pregabalin in the Treatment of Essential Tremor
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 diagnosed with ET tolerate high dose of pregabalin? Will the pregabalin be considered as an efficient medicine in the treatment of ET?
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A 17 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSS-OVER TRIAL OF PREGABALIN IN ESSENTIAL TREMOR|
- 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 ] [ Designated as safety issue: Yes ]
- Nonparametric tests will be employed and exact p (2 tailed) values computed for the categorical dependent variables. [ Time Frame: baseline to completion ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Pregabalin 75 mg bid to a maximum dose of 300 mg bid
75 mg bid to 300 mg bid based on per subject tolerability
Other Name: Lyrica
Placebo Comparator: 2
Placebo to 4 capsules bid
Drug: placebo capsules
up to 4 capsules bid as tolerated