Trial record 10 of 52 for:
"Benign essential tremor syndrome"
Pregabalin (Lyrica) for the Treatment of Essential Tremor
This study has been completed.
Sponsor:
University of South Florida
Collaborator:
Pfizer
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida
ClinicalTrials.gov Identifier:
NCT00584376
First received: December 20, 2007
Last updated: June 15, 2012
Last verified: June 2012
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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 4 |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
essential tremor
MedlinePlus related topics:
Tremor
Drug Information available for:
Pregabalin
U.S. FDA Resources
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 ]
| Enrollment: | 29 |
| Study Start Date: | December 2007 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (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 |
Criteria
Inclusion Criteria:
- Outpatients with essential tremor diagnosed by a movement disorder specialist.
- Age 18 years to 80 years.
- Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.
- Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
- Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).
- 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).
- Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
Exclusion Criteria:
- Any illness that in the investigator's opinion preclude participation in this study.
- Pregnancy or lactation.
- Concurrent participation in another clinical study.
- Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
- Legal incapacity or limited legal capacity.
- Presence of severe renal disease (BUN 50% greater than normal or creatine clearance <60 mL/min) or hepatic disease.
- Presence of severe daytime sleepiness.
- Abnormal creatine kinase and/or platelet count in the past year.
- Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
- Previous lack of response to other ET therapies (propranolol AND primidone).
- Patients who have had deep brain stimulation (DBS).
- Concomitant treatment with gabapentin.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584376
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 | |
Sponsors and Collaborators
University of South Florida
Pfizer
Investigators
| Principal Investigator: | Theresa A Zesiewicz, MD | University of South Florida |
More Information
No publications provided
| Responsible Party: | Theresa Zesiewicz, Professor, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00584376 History of Changes |
| Other Study ID Numbers: | 2 |
| Study First Received: | December 20, 2007 |
| Last Updated: | June 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
Essential tremor tremor pregabalin lyrica |
Additional relevant MeSH terms:
|
Essential Tremor 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 |
ClinicalTrials.gov processed this record on May 16, 2013