CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Octanoic Aciddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01468948
NCT01468948Phase 1Completed

Dose Escalation Study of Oral Octanoic Acid in Patients With Essential Tremor

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Nov 10, 2011·Updated Dec 16, 2019

In Brief

A Phase 1 clinical trial evaluating Octanoic Acid for Essential Tremor. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartOct 28, 2011
Primary CompletionJul 18, 2012
TodayJul 1, 2026
Enrollment to primary: 9 monthsPosted 14.6 years ago

Interventions

Octanoic Aciddrug