Clinical trial: A Proof of Concept Study of the Effectiveness of Carisbamate in the Treatment of Essential Tremor (NCT00524056)

Eligibility criteria:
Inclusion Criteria:

          -  Patients in good general health

          -  Definite ET based on the TRIG diagnostic criteria

          -  Patients must have tremor affecting both upper extremities and at least 1 upper
             extremity must have a postural or action/intention tremor that is rated from 2
             (moderate) to 4 (severe) as defined in Part A (Tremor location/severity rating) of the
             TRS at the Visit 2 evaluation

          -  Patients must have a negative urine drug screen at screening with exceptions for
             legally prescribed benzodiazepines or opioid analgesics. Patients must have a negative
             blood alcohol test at screening and be willing to abstain from alcohol for at least 24
             hours prior to each study visit.

        Exclusion Criteria:

          -  Abnormal neurologic signs or progressive neurological disorders, such as Parkinson's
             Disease, brain tumor, demyelinating disease, CNS trauma, active CNS infection, stroke,
             or any CNS disease, other than ET, that could interfere with the evaluation of tremor

          -  Patients with dystonia or dystonic tremors, enhanced physiologic tremor, task specific
             tremor (e.g., writing tremor), or historical or clinical evidence of psychogenic or
             fictitious movement disorders

          -  Patients currently taking or recently exposed to prohibited medications unless, in the
             opinion of the study investigator, the patient is able to follow the washout procedure
             and restrictions described in the protocol prior to randomization

          -  Patients taking more than one tremor-reducing agent who are unable to discontinue all
             or all but one of these medications

          -  Patients who have achieved no discernable tremor reduction after treatment with at
             least 2 of 3 following tremor-reducing medications specifically prescribed for the
             treatment of ET: propranolol, primidone, or topiramate

          -  Prior exposure to carisbamate (RWJ-333369)

          -  Surgical procedures for treatment of ET such as deep brain stimulation or thalamic
             ablation

          -  Current or past (within 1 year) major psychotic disorder, such as schizophrenia or
             other psychotic conditions, major depressive disorder with psychotic features or other
             psychiatric disorders

          -  Exacerbation of major depression within the past 6 months

          -  History of suicide attempts or suicidal ideation in the past year

          -  History of drug or alcohol abuse within the past year

          -  Patients who are not able to abstain from alcohol consumption for 24 hours prior to
             each evaluation

          -  Patients with abnormal screening laboratory values or ECG (electrical heart tracing)

          -  Patients with a history, diagnosis or clinical signs for a significant major medical
             disorder that might disqualify.
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 85 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