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Pregabalin in the Treatment of Essential Tremor

Information source: Baylor College of Medicine
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Tremor

Intervention: pregabalin (Drug); placebo capsules (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Baylor College of Medicine

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 diagnosed with ET tolerate high dose of pregabalin? Will the pregabalin be considered as an efficient medicine in the treatment of ET?

Clinical Details

Official title: A 17 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSS-OVER TRIAL OF PREGABALIN IN ESSENTIAL TREMOR

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

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.

Secondary outcome: Nonparametric tests will be employed and exact p (2 tailed) values computed for the categorical dependent variables.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Subjects must be between the ages of 18 and 80 inclusive.

2. Each subject must have current manifestations of ET symptoms based on the Tremor

Investigational Group (TRIG) criteria for definite or probable ET: - Moderate or

severe tremor in head or arms for at least 3 years duration. - No present causes of

enhanced physiologic tremor. - No recent exposure to tremorogenic drugs or drug

withdrawal states. - No direct or indirect trauma to the nervous system within 3

months preceding the onset of tremor. - No historic or clinical evidence of

psychogenic tremor origin.

3. Subjects with a history of seizures are eligible.

4. Subjects must be in generally good health as evidenced by previous medical history and clinical examination.

5. Patients will be allowed to take Beta-blockers but will not be allowed to take any other medication for tremor (primidone, topiramate, benzodiazepines, etc.) An evening dose of a benzodiazepine to improve sleep is acceptable. They must have been on a stable dose of any existing beta-blocker for 4 weeks prior to entry into the study and will not be allowed to change the dose of that medication throughout the controlled portion of the study. Any medication discontinued during screening in order to comply with these criteria must be stopped for 5 half-lives prior to study initiation.

6. Subjects must be accessible by telephone.

7. If the subject is a female of childbearing age, she must have had a hysterectomy, tubal ligation, otherwise be incapable of pregnancy, or have practiced one of the following methods of contraception for at least one month prior to study entry (or a

negative urine pregnancy test within one week of study entry): - Hormonal

contraceptives - Spermicide and barrier - Intrauterine device - Partner sterility

8. Prior to participation in this study, each subject must sign an informed consent.

Exclusion Criteria:

1. Patients do not meet TRIG criteria for probable ET.

2. Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.

3. Patients who can not maintain an identical dose of any medicine that may affect tremor during their entire study involvement.

4. Subjects who have exhibited any psychotic symptomatology.

5. Subjects who have known renal deficiencies.

6. Subjects who have been intolerant of pregabalin in the past

7. Prior surgical treatment for tremor.

8. Patients currently taking more than a single drug for ET.

9. Patients taking anti-seizure medications.

10. Breast feeding or pregnant females.

Locations and Contacts

PDCMDC 6550 Fannin, Suite 1801, Houston, Texas 77030, United States; Recruiting
Lina Shinawi, CCRC, Phone: 713-798-5519, Email: lshinawi@bcm.edu
William G Ondo, MD, Principal Investigator
Joseph Jankovic, MD, Sub-Investigator
Joohi Jimenez-Shahed, MD, Sub-Investigator
Additional Information

Starting date: June 2006
Ending date: December 2009
Last updated: March 26, 2008

Page last updated: November 03, 2008

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