Pregabalin (Lyrica) for the Treatment of Essential Tremor
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00584376 |
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Recruitment Status :
Completed
First Posted : January 2, 2008
Last Update Posted : June 18, 2012
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Sponsor:
University of South Florida
Collaborator:
Pfizer
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Essential Tremor | Drug: Pregabalin Drug: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 29 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, 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 |
| Study Start Date : | December 2007 |
| Actual Primary Completion Date : | November 2010 |
| Actual Study Completion Date : | November 2010 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Essential tremor
MedlinePlus related topics:
Tremor
Drug Information available for:
Pregabalin
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Pregabalin
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Drug: Pregabalin
Gradually titrated dose ranging from 75mg po bid to 225mg po bid. |
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Placebo Comparator: 2
Placebo
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Drug: Placebo
Placebo capsules which are identical in packaging, appearance and dosing as the active capsules. |
Primary Outcome Measures :
- Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score [ Time Frame: 61 days ]
Secondary Outcome Measures :
- Writing tablet recordings of tremor amplitude [ Time Frame: 61 days ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Theresa Zesiewicz, Professor, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00584376 History of Changes |
| Other Study ID Numbers: |
2 |
| First Posted: | January 2, 2008 Key Record Dates |
| Last Update Posted: | June 18, 2012 |
| Last Verified: | June 2012 |
Keywords provided by Theresa Zesiewicz, University of South Florida:
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Essential tremor tremor pregabalin lyrica |
Additional relevant MeSH terms:
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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 Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |