Clinical trial: Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor (NCT00848172)

Eligibility criteria:
-  INCLUSION CRITERIA:

          -  Male or female patients with alcohol-responsive ET according to published clinical
             criteria

          -  Tremor in both upper limbs should be predominant feature of ET

          -  Subjects must be willing and safely able to comply with the study protocol and
             therefore abstain from any medication for the treatment of tremor for a period of at
             least 5 plasma half-lives of the individual drug prior to study participation. (For
             Propranolol/Inderal(Registered Trademark), Gabapentin/Neurontin(Registered Trademark),
             Topiramate/Topamax(Registered Trademark) this will be 4 days; for
             Primidone/Mysoline(Registered Trademark): 28 days).

          -  Subjects must be willing to refrain from alcohol and caffeine intake starting 48 hr
             prior to hospitalization until study termination

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

        EXCLUSION CRITERIA:

          -  Patients with any other significant pathological finding in the neurological
             examination other than typical symptoms of ET

          -  Acute or chronic severe medical conditions which would preclude the subject from
             participating (e.g., severe heart disease NYHA grade 3 or 4, renal failure, hepatic
             failure, lung disease, uncontrolled hyperthyroidism)

          -  Subjects with diabetes mellitus, hypoglycemia or severe hyperlipidemia (must be
             documented by referring physician with copy of last fasting routine blood test within
             one year before the screening visit including glucose and lipid levels; according to
             NIH guidelines, fasting LDL levels of greater than or equal to 160 mg/dl are
             considered severe hyperlipidemia; if under treatment, LDL-levels less than 160 have to
             be documented to be eligible for the study)

          -  Subjects with active or past alcohol abuse or dependence

          -  Subjects with concomitant therapy with warfarin or NSAIDs, when taken on a regular
             basis and cannot be discontinued at least 14 days prior to study participation,
             because of potential interactions with octanoic acid (displacement of albumin binding
             in human serum)

          -  Subjects with clinically significant abnormalities on their baseline laboratory tests

          -  Subjects aged less than 21 years

          -  Female subjects who are pregnant or lactating

          -  Subjects with cognitive impairment interfering with the ability to give informed
             consent or to cooperate during the study

          -  Subjects 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

          -  Subjects where no written informed consent is received or subjects who are unwilling
             to cooperate during the study
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