Pregabalin (Lyrica) for the Treatment of Essential Tremor

Completed · Phase 4 · Has a placebo group

Conditions studied: Essential Tremor

In brief

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.

Key facts

Study ID

NCT00584376

Run by

University of South Florida

People needed

29

Starts

2007-12-01

Expected to finish

2010-11-01

Last updated by the study team

2012-06-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatients with essential tremor diagnosed by a movement disorder specialist.
• Age 18 years to 80 years.
• Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.
• Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
• Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).
• 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).
• Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

You may not qualify if…

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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of South Florida — Tampa, Florida, United States
• Emory Univ. School of Medicine — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Southern Illinois U. School of Medicine — Springfield, Illinois, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• Vanderbilt — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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