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Pregabalin (Lyrica) for the Treatment of Essential Tremor

Information source: University of South Florida
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Tremor

Intervention: Pregabalin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Theresa A Zesiewicz, MD, Principal Investigator, Affiliation: University of South Florida

Overall contact:
Kelly Sullivan, MSPH, Phone: 813-974-5909, Email: kbarber@hsc.usf.edu

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.

Clinical Details

Official title: A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor

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

Primary outcome: Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score

Secondary outcome: Writing tablet recordings of tremor amplitude

Eligibility

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

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.

Locations and Contacts

Kelly Sullivan, MSPH, Phone: 813-974-5909, Email: kbarber@hsc.usf.edu

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Rachel Clark, RN, Phone: 205-934-0683
Natividad Stover, MD, Principal Investigator

University of South Florida, Tampa, Florida 33612, United States; Recruiting

Emory Univ. School of Medicine, Atlanta, Georgia 30329, United States; Recruiting
Barbara Sommerfeld, Phone: 404-728-6944, Email: bsommer@emory.edu
Alan Freeman, MD, Principal Investigator

Medical College of Georgia, Augusta, Georgia 30912, United States; Recruiting
Paula Jackson, Phone: 706-721-2798, Email: pjackson@mcg.edu
John Morgan, MD PhD, Principal Investigator

Southern Illinois U. School of Medicine, Springfield, Illinois 62794, United States; Recruiting
Dolly Kelley, RN, CCRC, Phone: 217-545-7829, Email: dkelley@siumed.edu
Rodger Elble, MD, PhD, Principal Investigator

Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Jennifer Zimmerman, RN, Phone: 843-792-9115, Email: zimmerj@musc.edu
Vanessa Hinson, MD, Principal Investigator

University of Tennessee Health Science Center, Memphis, Tennessee 38163, United States; Recruiting
Joel Dennhardt, BS, Phone: 901-448-6180, Email: jdennhar@utmem.edu
Mark LeDoux, MD, Principal Investigator

Additional Information

Starting date: December 2007
Ending date: December 2009
Last updated: July 15, 2009

Page last updated: October 19, 2009

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