Status:
COMPLETED
Octanoic Acid for Essential Tremor
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Essential Tremor
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
Background: \- Essential tremor (ET) is a condition of out-of-control shaking. Several drugs are used to treat ET. However, they are often only partly helpful and can have side effects. Many people w...
Detailed Description
OBJECTIVE: To determine the maximum tolerated dose of oral octanoic acid (OA) in patients with essential tremor. Further study objectives include the evaluation of the efficacy and tolerability of oc...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01468948
Start Date
October 28 2011
End Date
July 18 2012
Last Update
December 16 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892