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NCT01468948 · ClinicalTrials.gov registry record · Phase 1
Octanoic Acid for Essential Tremor
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01468948 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 18 participants.
The verdict
NCT01468948, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study 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 with ET get some relief from drinking alcohol. Octanol, a food additive similar to alcohol, can improve tremor in animals and is less likely to make people feel drunk. One form of octanol, called 1-octanol, has been shown to improve tremor in some people and had few side effects. 1-octanol is converted to octanoic acid, and research suggests that octanoic acid itself might suppress ET with no significant side effects such as drunkenness. Researchers want to see what dose of octanoic acid is most useful in reducing ET. Objectives: \- To test different doses of octanoic acid to treat essential tremor. Eligibility: * Individuals at least 21 years of age who have ET that responds to treatment with alcohol. * Participants must be able to stop taking certain ET medications during the study. Design: * This study requires three visits. Visit 1 is a screening visit that will take up to 5 hours. Visit 2 is a 2- to 3-day inpatient admission to the National Institutes of Health Clinical Center. Visit 3 is a followup outpatient visit 1 to 2 weeks after the hospital admission. * At the screening visit, participants will have a physical exam, neurological exam, and medical history. Blood and urine samples will be collected. Participants will also have an alcohol dose test to measure the tremor s response to alcohol. * For the study visit, participants will enter the hospital for testing. Participants will have the study drug and test the tremor's response to it. Frequent blood samples will be collected. * One to two weeks after leaving the hospital, participants will have a final followup study visit. Blood samples will be collected.
Interventions
- DRUG Octanoic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-10-28 |
| Est. Completion | 2012-07-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01468948
The ClinicalTrials.gov registry entry for NCT01468948 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 1 intervention - of which Octanoic Acid is the first listed.
NCT01468948 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01468948 about?
NCT01468948 is a clinical study titled "Octanoic Acid for Essential Tremor". 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 with ET get some relief from drinking alcohol. Octanol, a food additive similar to alcohol, can impro...
What is the current status of trial NCT01468948?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-10-28. Estimated completion is 2012-07-18.
What interventions are being tested in trial NCT01468948?
The interventions under investigation include: Octanoic Acid (DRUG).
Who is sponsoring clinical trial NCT01468948?
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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