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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 |
| 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 |
|---|---|
|
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 |
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 | |
| United States, Georgia | |
| Emory Univ. School of Medicine | Recruiting |
| Atlanta, Georgia, United States, 30329 | |
| Contact: Barbara Sommerfeld 404-728-6944 bsommer@emory.edu | |
| Principal Investigator: Alan Freeman, MD | |
| Medical College of Georgia | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| Contact: Paula Jackson 706-721-2798 pjackson@mcg.edu | |
| Principal Investigator: John Morgan, MD PhD | |
| 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 | |
| United States, Tennessee | |
| University of Tennessee Health Science Center | Recruiting |
| Memphis, Tennessee, United States, 38163 | |
| Contact: Joel Dennhardt, BS 901-448-6180 jdennhar@utmem.edu | |
| Principal Investigator: Mark LeDoux, MD | |
| 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 |
| Study First Received: | December 20, 2007 |
| Last Updated: | June 2, 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 |