Clinical trial: Clinical Trial Characterizing the Bioavailability of 1-Octanol in Adults With Ethanol-responsive Essential Tremor (NCT00102596)

Eligibility criteria:
INCLUSION CRITERIA:

          -  Patients with alcohol-responsive Essential Tremor

          -  Limb involvement should be a prominent feature of the Essential tremor

          -  Patients must be willing and able to safely stop and remain off any medications used
             to treat essential tremor for at least 4 half-lives

          -  Patients must be willing to abstain from ethanol and caffeine intake for at least 48
             hours prior to starting the study hospitalization until study termination

          -  Patients must be willing and able to fast for periods of up to 12 hours during the
             study

        EXCLUSION CRITERIA:

          -  Patients with abnormalities other than tremor on neurological exam

          -  Patients with active or past alcohol abuse or dependence

          -  Patients with acute or chronic severe medical conditions such as renal failure,
             hepatic failure or lung disease

          -  Patients taking primidone

          -  Patients on other acute or chronic medications that influence hepatic metabolism or
             central nervous system (CNS) function and cannot be temporarily discontinued for the
             length of the study

          -  Patients who do not wish to take a potentially intoxicating drug

          -  Patients with abnormalities on their baseline screening laboratory tests

          -  Women who are pregnant or lactating

          -  Patients younger than age 21

          -  The presence of cognitive impairment preventing informed consent or cooperation during
             the study

          -  People of Far East Asian or Native American descent, who may possess variant alleles
             of the genes for alcohol metabolism, i.e., alcohol dehydrogenase and aldehyde
             dehydrogenase, resulting in altered (slower) metabolism and potentially increased
             sensitivity to alcohols and their metabolites
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 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