Working… Menu

Pregabalin (Lyrica) for the Treatment of Essential Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00584376
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : June 18, 2012
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor
Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: 1
Drug: Pregabalin
Gradually titrated dose ranging from 75mg po bid to 225mg po bid.

Placebo Comparator: 2
Drug: Placebo
Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00584376

Layout table for location information
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
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
University of South Florida
Layout table for investigator information
Principal Investigator: Theresa A Zesiewicz, MD University of South Florida

Layout table for additonal information
Responsible Party: Theresa Zesiewicz, Professor, University of South Florida Identifier: NCT00584376     History of Changes
Other Study ID Numbers: 2
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012
Keywords provided by Theresa Zesiewicz, University of South Florida:
Essential tremor
Additional relevant MeSH terms:
Layout table for MeSH terms
Essential Tremor
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs