Trial record 10 of 65 for:    "Benign essential tremor syndrome"

Pregabalin (Lyrica) for the Treatment of Essential Tremor

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida
ClinicalTrials.gov Identifier:
NCT00584376
First received: December 20, 2007
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Essential Tremor
Drug: Pregabalin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor

Resource links provided by NLM:


Further study details as provided by University of South Florida:

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

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

Enrollment: 29
Study Start Date: December 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pregabalin
Drug: Pregabalin
Gradually titrated dose ranging from 75mg po bid to 225mg po bid.
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584376

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory Univ. School of Medicine
Atlanta, Georgia, United States, 30329
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
Southern Illinois U. School of Medicine
Springfield, Illinois, United States, 62794
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
University of South Florida
Pfizer
Investigators
Principal Investigator: Theresa A Zesiewicz, MD University of South Florida
  More Information

No publications provided

Responsible Party: Theresa Zesiewicz, Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT00584376     History of Changes
Other Study ID Numbers: 2
Study First Received: December 20, 2007
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Essential tremor
tremor
pregabalin
lyrica

Additional relevant MeSH terms:
Essential Tremor
Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 17, 2014