Pregabalin (Lyrica) for the Treatment of Essential Tremor - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

July 15, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score [ Time Frame: 61 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00584376 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Writing tablet recordings of tremor amplitude [ Time Frame: 61 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Pregabalin (Lyrica) for the Treatment of Essential Tremor

Official Title ^ICMJE

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

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Essential Tremor

Intervention ^ICMJE

Drug: Pregabalin
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: Pregabalin
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kelly Sullivan, MSPH

813-974-5909

kbarber@hsc.usf.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00584376

Responsible Party

Theresa Zesiewicz, MD, University of South Florida

Study ID Numbers ^ICMJE

Study Sponsor ^ICMJE

University of South Florida

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Principal Investigator:

Theresa A Zesiewicz, MD

University of South Florida

Information Provided By

University of South Florida

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP