Clinical trial: Pregabalin in the Treatment of Essential Tremor (NCT00646451)

Eligibility criteria:
Inclusion Criteria:

          1. Subjects must be between the ages of 18 and 80 inclusive.

          2. Each subject must have current manifestations of ET symptoms based on the Tremor
             Investigational Group (TRIG) criteria for definite or probable ET: - Moderate or
             severe tremor in head or arms for at least 3 years duration. - No present causes of
             enhanced physiologic tremor. - No recent exposure to tremorogenic drugs or drug
             withdrawal states. - No direct or indirect trauma to the nervous system within 3
             months preceding the onset of tremor. - No historic or clinical evidence of
             psychogenic tremor origin.

          3. Subjects with a history of seizures are eligible.

          4. Subjects must be in generally good health as evidenced by previous medical history and
             clinical examination.

          5. Patients will be allowed to take Beta-blockers but will not be allowed to take any
             other medication for tremor (primidone, topiramate, benzodiazepines, etc.) An evening
             dose of a benzodiazepine to improve sleep is acceptable. They must have been on a
             stable dose of any existing beta-blocker for 4 weeks prior to entry into the study and
             will not be allowed to change the dose of that medication throughout the controlled
             portion of the study. Any medication discontinued during screening in order to comply
             with these criteria must be stopped for 5 half-lives prior to study initiation.

          6. Subjects must be accessible by telephone.

          7. If the subject is a female of childbearing age, she must have had a hysterectomy,
             tubal ligation, otherwise be incapable of pregnancy, or have practiced one of the
             following methods of contraception for at least one month prior to study entry (or a
             negative urine pregnancy test within one week of study entry): - Hormonal
             contraceptives - Spermicide and barrier - Intrauterine device - Partner sterility

          8. Prior to participation in this study, each subject must sign an informed consent.

        Exclusion Criteria:

          1. Patients do not meet TRIG criteria for probable ET.

          2. Subjects who are not able to abstain from alcohol for 24 hours prior to each
             evaluation.

          3. Patients who can not maintain an identical dose of any medicine that may affect tremor
             during their entire study involvement.

          4. Subjects who have exhibited any psychotic symptomatology.

          5. Subjects who have known renal deficiencies.

          6. Subjects who have been intolerant of pregabalin in the past

          7. Prior surgical treatment for tremor.

          8. Patients currently taking more than a single drug for ET.

          9. Patients taking anti-seizure medications.

         10. Breast feeding or pregnant females.
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