Pregabalin (Lyrica) for the Treatment of Essential Tremor

Study Description

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Brief Summary:

This will be a multi-site, prospective, double-blind, randomized, placebo-controlled, crossover trial conducted over 6 months to assess the effectiveness and safety of PGB to treat symptoms of ET.

Condition or disease	Intervention/treatment	Phase
Essential Tremor	Drug: Pregabalin; Drug: Placebo	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor
Study Start Date :	December 2007
Actual Primary Completion Date :	November 2010
Actual Study Completion Date :	November 2010

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1; Pregabalin	Drug: Pregabalin; Gradually titrated dose ranging from 75mg po bid to 225mg po bid.
Placebo Comparator: 2; Placebo	Drug: Placebo; Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.

Outcome Measures

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Primary Outcome Measures :

1. Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score [ Time Frame: 61 days ]

Secondary Outcome Measures :

1. Writing tablet recordings of tremor amplitude [ Time Frame: 61 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Outpatients with essential tremor diagnosed by a movement disorder specialist.
2. Age 18 years to 80 years.
3. Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.
4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
5. Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).
6. Serum creatine kinase, complete metabolic blood count, liver function tests, renal function tests, and platelets are within normal limits (blood drawn within the past year).
7. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
5. Legal incapacity or limited legal capacity.
6. Presence of severe renal disease (BUN 50% greater than normal or creatine clearance <60 mL/min) or hepatic disease.
7. Presence of severe daytime sleepiness.
8. Abnormal creatine kinase and/or platelet count in the past year.
9. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
10. Previous lack of response to other ET therapies (propranolol AND primidone).
11. Patients who have had deep brain stimulation (DBS).
12. Concomitant treatment with gabapentin.

Contacts and Locations

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Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory Univ. School of Medicine
Atlanta, Georgia, United States, 30329
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Southern Illinois U. School of Medicine
Springfield, Illinois, United States, 62794
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Vanderbilt
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

University of South Florida

Pfizer

Investigators

Principal Investigator:	Theresa A Zesiewicz, MD	University of South Florida

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Theresa Zesiewicz, Professor, University of South Florida
ClinicalTrials.gov Identifier:	NCT00584376 History of Changes
Other Study ID Numbers:	2
First Posted:	January 2, 2008
Last Update Posted:	June 18, 2012
Last Verified:	June 2012

Keywords provided by Theresa Zesiewicz, University of South Florida:

Essential tremor; tremor; pregabalin; lyrica

Additional relevant MeSH terms:

Tremor; Essential Tremor; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Pregabalin; Analgesics; Sensory System Agents	Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs