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| 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 |
| 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 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.
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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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Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kelly Sullivan, MSPH | 813-974-5909 | kbarber@hsc.usf.edu |
| United States, Florida | |||||
| University of South Florida | Recruiting | ||||
| Tampa, Florida, United States, 33612 | |||||
| University of South Florida |
| Pfizer |
| 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 |
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