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Pregabalin (Lyrica) for the Treatment of Essential Tremor

This study is currently recruiting participants.
Verified by University of South Florida, June 2008

Sponsors and Collaborators: University of South Florida
Pfizer
Information provided by: University of South Florida
ClinicalTrials.gov Identifier: NCT00584376
  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 IV

Genetics Home Reference related topics:   essential tremor    familial paroxysmal nonkinesigenic dyskinesia   

MedlinePlus related topics:   Tremor   

ChemIDplus related topics:   Pregabalin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:   A Multi-Site, Double-Blind, Randomized, Placebo-Controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor

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 ]

Estimated Enrollment:   62
Study Start Date:   December 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Pregabalin
Drug: Pregabalin
Gradually titrated dose ranging from 75mg po bid to 225mg po bid.
2: Placebo Comparator
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

Contacts
Contact: Kelly Sullivan, MSPH     813-974-5909     kbarber@hsc.usf.edu    

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

Sponsors and Collaborators
University of South Florida
Pfizer

Investigators
Principal Investigator:     Theresa A Zesiewicz, MD     University of South Florida    
  More Information


Responsible Party:   University of South Florida ( Theresa Zesiewicz, MD )
Study ID Numbers:   2
First Received:   December 20, 2007
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00584376
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Signs and Symptoms
Essential Tremor
Movement Disorders
Benign essential tremor syndrome
Pregabalin
Central Nervous System Diseases
Neurologic Manifestations
Dyskinesias
Tremor

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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