Status:
COMPLETED
Clinical Trial Characterizing the Bioavailability of 1-Octanol in Adults With Ethanol-responsive Essential Tremor
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Essential Tremor
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
OVERVIEW Essential tremor (ET) is a common movement disorder affecting 0.4% of the general population and up to 14% of people 65 years and older. Response to medications such as beta blockers and pri...
Detailed Description
OVERVIEW Essential tremor (ET) is a common movement disorder affecting 0.4% of the general population and up to 14% of people 65 years and older. Response to medications such as beta blockers and pri...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00102596
Start Date
January 1 2005
End Date
September 1 2009
Last Update
February 1 2012
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892