Clinical trial NCT00584376: Pregabalin (Lyrica) for the Treatment of Essential Tremor
Official title: A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Tremor
Keywords: Essential tremor
tremor
pregabalin
lyrica
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-01-02
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Outpatients with essential tremor diagnosed by a movement disorder specialist.
2. Age 18 years to 80 years.
3. Postural tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the FTM rating scale.
4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
5. Baseline EKG read as within normal limits (no clinically significant abnormalities)obtained from primary care physician or cardiologist (performed within the past year).
6. 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).
7. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
5. Legal incapacity or limited legal capacity.
6. Presence of severe renal disease (BUN 50% greater than normal or creatine clearance \<60 mL/min) or hepatic disease.
7. Presence of severe daytime sleepiness.
8. Abnormal creatine kinase and/or platelet count in the past year.
9. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities.
10. Previous lack of response to other ET therapies (propranolol AND primidone).
11. Patients who have had deep brain stimulation (DBS).
12. Concomitant treatment with gabapentin.

Primary outcomes:
measure: Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score
timeFrame: 61 days
Secondary outcomes:
measure: Writing tablet recordings of tremor amplitude
timeFrame: 61 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory Univ. School of Medicine
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois U. School of Medicine
state: Illinois
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
Study officials:
affiliation: University of South Florida
name: Theresa A Zesiewicz, MD
role: PRINCIPAL_INVESTIGATOR
References: