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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00848172 |
Background:
Octanol is less likely to make people drunk than alcohol. Two earlier NIH studies found that one form of octanol, called 1-octanol, did improve tremor in some people and had few side effects.
Objectives:
Eligibility:
Design:
Patients may not drink alcohol or eat or drink anything with caffeine, including chocolate, for at least 2 days before admission.
Condition | Intervention | Phase |
---|---|---|
Essential Tremor |
Drug: Octanoic Acid |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Placebo Controlled Pilot-Study of Octanoic Acid in Essential Tremor |
Estimated Enrollment: | 45 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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
Octanoic acid will be tested in a double-blind, randomized, placebo-controlled, cross-over design in 19 patients with essential tremor. The active study medication and placebo will be administered as oral single morning doses on consecutive days in a randomized sequence. All subjects will receive a dose that was defined as being safe according to available toxicity data (4mg/kg) and will be monitored closely during the total inpatient study phase of three days (day 0: baseline; days 1-2: active study days).
Outcome measures
The primary outcome measure for this study will be the effect on tremor power of the dominant hand, 80 minutes after administration of the study substance, compared to placebo. Tremor power will be measured using accelerometry with loading to test central tremor component. Secondary outcome measures include recordings of tremor power as measured by accelerometry at multiple other time points up to 300 min after administration, also recorded from the non-dominant hand and without loading. The change in tremor severity documented by spirography and actigraphy as well as data collected regarding drug safety (laboratory testing, documentation of vital signs, adverse events questionnaire and intoxication scale) as well as the pharmacokinetic and pharmacodynamic properties will act as further secondary outcome parameters.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | National Institutes of Health ( Mark Hallett, M.D./National Institute of Neurological Disorders and Stroke ) |
Study ID Numbers: | 090084, 09-N-0084 |
Study First Received: | February 19, 2009 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00848172 History of Changes |
Health Authority: | United States: Federal Government |
Essential Tremor Octanol Octanoic Acid |
Ethanol Accelerometry Essential Tremor |
Signs and Symptoms Essential Tremor Movement Disorders Central Nervous System Diseases Neurologic Manifestations |
Benign Essential Tremor Syndrome Dyskinesias Tremor Ethanol |
Signs and Symptoms Essential Tremor Movement Disorders Nervous System Diseases |
Central Nervous System Diseases Neurologic Manifestations Dyskinesias Tremor |