Pregabalin (Lyrica) for the Treatment of Essential Tremor

Phase 4

Completed

• Conditions: Essential Tremor
• Interventions: Drug: Placebo; Drug: Pregabalin

• Registration Number: NCT00584376
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2008-01-02
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-15
• Last Update Posted: 2012-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Pregabalin	Pregabalin

Primary Outcome Measures

Name	Time	Method
Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score	61 days

Secondary Outcome Measures

Name	Time	Method
Writing tablet recordings of tremor amplitude	61 days

Trial Locations

Locations (8)

Emory Univ. School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Medical College of Georgia; 🇺🇸 Augusta, Georgia, United States

Vanderbilt; 🇺🇸 Nashville, Tennessee, United States

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Southern Illinois U. School of Medicine; 🇺🇸 Springfield, Illinois, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States