Pregabalin in the Treatment of Essential Tremor - Full Text View

Sponsors and Collaborators:	Baylor College of Medicine Pfizer
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00646451

Purpose

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?

Condition	Intervention	Phase
Essential Tremor	Drug: pregabalin Drug: placebo capsules	Phase IV

Genetics Home Reference related topics: essential tremor familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Tremor

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A 17 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, CROSS-OVER TRIAL OF PREGABALIN IN ESSENTIAL TREMOR

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Pregabalin 75 mg bid to a maximum dose of 300 mg bid	Drug: pregabalin 75 mg bid to 300 mg bid based on per subject tolerability
2: Placebo Comparator Placebo to 4 capsules bid	Drug: placebo capsules up to 4 capsules bid as tolerated

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must be between the ages of 18 and 80 inclusive.
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.
Subjects with a history of seizures are eligible.
Subjects must be in generally good health as evidenced by previous medical history and clinical examination.
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.
Subjects must be accessible by telephone.
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
Prior to participation in this study, each subject must sign an informed consent.

Exclusion Criteria:

Patients do not meet TRIG criteria for probable ET.
Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation.
Patients who can not maintain an identical dose of any medicine that may affect tremor during their entire study involvement.
Subjects who have exhibited any psychotic symptomatology.
Subjects who have known renal deficiencies.
Subjects who have been intolerant of pregabalin in the past
Prior surgical treatment for tremor.
Patients currently taking more than a single drug for ET.
Patients taking anti-seizure medications.
Breast feeding or pregnant females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646451

Locations

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

Sponsors and Collaborators

Baylor College of Medicine

Pfizer

More Information

Responsible Party:	Baylor College of Medicine ( William G. Ondo, MD )
Study ID Numbers:	H-19086
Study First Received:	December 28, 2007
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00646451
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Essential tremor
Activities of Daily Living (ADL's)

Study placed in the following topic categories:

Signs and Symptoms
Essential Tremor
Movement Disorders
Benign essential tremor syndrome
Pregabalin

Central Nervous System Diseases
Neurologic Manifestations
Dyskinesias
Tremor

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009