Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor

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