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Pregabalin (Lyrica) for the Treatment of Essential Tremor

Primary Purpose

Essential Tremor

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor focused on measuring Essential tremor, tremor, pregabalin, lyrica

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of South Florida
  • Emory Univ. School of Medicine
  • Medical College of Georgia
  • Southern Illinois U. School of Medicine
  • Medical University of South Carolina
  • University of Tennessee Health Science Center
  • Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Pregabalin

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Writing tablet recordings of tremor amplitude

Full Information

First Posted
December 20, 2007
Last Updated
June 15, 2012
Sponsor
University of South Florida
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00584376
Brief Title
Pregabalin (Lyrica) for the Treatment of Essential Tremor
Official Title
A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
Essential tremor, tremor, pregabalin, lyrica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pregabalin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Gradually titrated dose ranging from 75mg po bid to 225mg po bid.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.
Primary Outcome Measure Information:
Title
Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score
Time Frame
61 days
Secondary Outcome Measure Information:
Title
Writing tablet recordings of tremor amplitude
Time Frame
61 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa A Zesiewicz, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Univ. School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Southern Illinois U. School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Pregabalin (Lyrica) for the Treatment of Essential Tremor

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