Clinical trial: Octanoic Acid for Essential Tremor (NCT01468948)

Eligibility criteria:
-  INCLUSION CRITERIA:

          -  Diagnosis of essential tremor with bilateral hand tremor as the predominant feature,
             which is known to be responsive to ethanol.

          -  Unequivocal accelerometric tremor of both hands on screening examination (bilateral
             central tremor component during postural tremor accelerometry, consistent with ET)

          -  Reduction of accelerometric tremor power of at least 35% following a formal ethanol
             challenge during the screening visit.

          -  Subjects must be willing and safely able to 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 , Gabapentin/Neurontin
             this will be 1 day; for Primidone/Mysoline : 26 days).

        Subjects must be willing to refrain from alcohol and drinks or food containing caffeine
        starting 48 hours prior to the study visits

        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 concomitant therapy with warfarin or NSAIDs (other than aspirin), 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)(Noctor et al. 1992)

          -  Established diagnosis of diabetes mellitus, as fasting-periods of up to 12 hours are
             required in the protocol.

          -  Subjects with active or past alcohol abuse or dependence (AUDIT score greater than or
             equal to 8)

          -  Elevated liver function parameters (AST, ALT, GGT), higher than the 1.5 fold upper
             limit of the normal range (as defined by the NIH Clinical Center Laboratory Medicine
             Department), or any other clinically significant abnormalities on their baseline
             laboratory tests. The limit for AST therefore will be 51 U/l, for ALT 62 U/L, and GGT
             128 U/l.

          -  Female subjects who are pregnant or breastfeeding

          -  Subjects aged < 21 years

          -  Known flushing symptoms after alcohol intake or allergy to alcohol (any yes answer in
             the standardized Alcohol Flushing Questionnaire)
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? 1