Pregabalin (Lyrica) for the Treatment of Essential Tremor

Study Overview
=================
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.

Official Title
-----------------
A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor

Conditions
-----------------
Essential Tremor

Intervention / Treatment
-----------------
* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pregabalin | Drug: Pregabalin<br>* Gradually titrated dose ranging from 75mg po bid to 225mg po bid.<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo capsules which are identical in packaging, appearance and dosing as the active capsules.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fahn-Tolosa-Marin Essential Tremor Rating Scale (FTM) total score |  | 61 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Writing tablet recordings of tremor amplitude |  | 61 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential tremor, tremor, pregabalin, lyrica