Clinical trial: Pregabalin (Lyrica) for the Treatment of Essential Tremor (NCT00584376)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago.  It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol.  Family history is significant for similar problems in his mother.  Vital signs are normal and the patient has no other medical conditions.  Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed.

Patient description (patient's own words): I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor.

Does the patient match the trial criteria? Entailment