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NCT00848172 · ClinicalTrials.gov registry record · Phase 1
Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT00848172 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 29 participants.
The verdict
NCT00848172, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study 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 have side effects. * Research studies have shown that octanol, a food additive similar to alcohol, can improve tremor in animals. 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. * In the body, 1-octanol is converted to octanoic acid. Researchers are interested in finding out whether octanoic acid can help people with ET. Objectives: * To find out if octanoic acid can improve hand tremor in people with essential tremor. * To measure levels of octanoic acid in the blood after it is taken. Eligibility: * Patients 21 years of age and older with ET, who are willing to abstain from alcohol, caffeine, and all medications as required by the study and who are willing and able to fast for up to 12 hours at a time. * Participants may not be of Asian or Native American ancestry because of genetic susceptibilities to the intoxicating effects of the study drug. Design: * This study requires a 3-day hospital admission as well as two outpatient visits. * Visit 1 (outpatient): Screening visit and blood alcohol level test * Medical history, physical and neurological examination, a blood test, and an electrocardiogram to measure heart function. Women who are able to get pregnant will have a urine pregnancy test. * Patients will consume 1.5 ounces of alcohol per drink (up to three drinks at least 30 minutes apart), and be tested to evaluate how the tremor responds. Researchers will draw blood to measure blood alcohol level about 1 hour after the first drink and closely monitor patients for signs of intoxication. * Inpatient examination * Preparation: Researchers will prepare a schedule to stop any tremor medications that patients might be on
Interventions
- DRUG Placebo
- DRUG Octanoic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00848172
The ClinicalTrials.gov registry entry for NCT00848172 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00848172 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00848172 about?
NCT00848172 is a clinical study titled "Double-Blind, Placebo Controlled Pilot Study of Octanoic Acid in Essential Tremor". 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 have side effects. * Research studies have shown that octanol, a food additive similar to alcohol, ...
What is the current status of trial NCT00848172?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2009-02. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00848172?
The interventions under investigation include: Placebo (DRUG), Octanoic Acid (DRUG).
Who is sponsoring clinical trial NCT00848172?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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