Clinical trial: A Safety/Efficacy Trial of Zonisamide for Essential Tremor (NCT00223743)

Eligibility criteria:
Inclusion Criteria:

          -  age 18 or older

          -  diagnosis of essential tremor

          -  tremor present in both hands for at least one year

          -  tremor is bothersome in at least one hand, so that reduction of tremor would improve
             quality of life

          -  able to comply with study visits and procedures

          -  has voluntarily signed consent form

          -  able to abstain from alcohol for 12 hours prior to each visit, and from caffeine on
             day prior to visit

          -  taking no medications or stable doses of anti-tremor medication for 4 weeks prior to
             the Baseline visit

        Exclusion Criteria:

          -  medical condition likely to cause hospitalization during the study

          -  progressive neurological disorder other than essential tremor

          -  history of serious psychiatric illness

          -  history of drug or alcohol abuse in past year

          -  consumes more than two glasses of wine or equivalent per day

          -  has received botulinum toxin injection in past 6 months

          -  currently using experimental device

          -  has taken experimental drug within 5 half lives of its elimination

          -  has received deep brain stimulation in past two weeks or has potential need for this
             therapy during the study

          -  thalamotomy within the past 6 months

          -  taking medications judged by investigator to exacerbate tremor

          -  has probable cause of tremor other than essential tremor

          -  condition likely to interfere with absorption, metabolism or elimination of study drug

          -  hepatic disease

          -  renal disease

          -  history of renal stones

          -  history of allergy to sulfonamides
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.


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