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| Sponsor: | University of South Florida |
|---|---|
| Collaborator: |
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 |
| 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 |
| 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 |
|---|---|
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Theresa A Zesiewicz, MD | University of South Florida |
More Information
| Responsible Party: | Theresa Zesiewicz, MD, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00584376 History of Changes |
| Other Study ID Numbers: | 2 |
| Study First Received: | December 20, 2007 |
| Last Updated: | February 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Essential tremor tremor pregabalin lyrica |
|
Tremor Essential 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 |