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Sponsors and Collaborators: |
University of South Florida Pfizer |
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Information provided by: | University of South Florida |
ClinicalTrials.gov Identifier: | NCT00584376 |
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 |
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Essential Tremor |
Drug: Pregabalin Drug: Placebo |
Phase IV |
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 |
Estimated Enrollment: | 62 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Pregabalin
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Drug: Pregabalin
Gradually titrated dose ranging from 75mg po bid to 225mg po bid.
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kelly Sullivan, MSPH | 813-974-5909 | kbarber@hsc.usf.edu |
United States, Florida | |
University of South Florida | Recruiting |
Tampa, Florida, United States, 33612 | |
United States, Illinois | |
Southern Illinois U. School of Medicine | Recruiting |
Springfield, Illinois, United States, 62794 | |
Contact: Dolly Kelley, RN, CCRC 217-545-7829 dkelley@siumed.edu | |
Principal Investigator: Rodger Elble, MD, PhD | |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Jennifer Zimmerman, RN 843-792-9115 zimmerj@musc.edu | |
Principal Investigator: Vanessa Hinson, MD |
Principal Investigator: | Theresa A Zesiewicz, MD | University of South Florida |
Responsible Party: | University of South Florida ( Theresa Zesiewicz, MD ) |
Study ID Numbers: | 2 |
Study First Received: | December 20, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00584376 History of Changes |
Health Authority: | United States: Institutional Review Board |
Essential tremor tremor pregabalin lyrica |
Signs and Symptoms Essential Tremor Movement Disorders Pregabalin Central Nervous System Diseases Neurologic Manifestations |
Peripheral Nervous System Agents Analgesics Benign Essential Tremor Syndrome Dyskinesias Tremor Anticonvulsants |
Essential Tremor Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases Pregabalin Tremor Dyskinesias Pharmacologic Actions Signs and Symptoms |
Movement Disorders Sensory System Agents Therapeutic Uses Neurologic Manifestations Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |