Status:
COMPLETED
Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Essential Tremor
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
Background: * Essential tremor (ET) is a neurological disorder characterized by uncontrollable shaking. Several medications are used to treat ET; however, they are often only partly effective and can...
Detailed Description
OBJECTIVE: We propose a study to examine the safety and efficacy of octanoic acid in essential tremor (ET). STUDY POPULATION: We will study 19 adult subjects with ethanol-responsive ET. DESIGN: O...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00848172
Start Date
February 1 2009
End Date
November 1 2010
Last Update
December 27 2012
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892