Double-Blind, Placebo-Controlled, Single-Dose Trial of 1-Octanol in Essential Tremor
1-Octanol
Central Nervous System Diseases+6
+ Movement Disorders
+ Nervous System Diseases
Treatment Study
Summary
Study start date: January 1, 2000
Actual date on which the first participant was enrolled.Essential tremor (ET) is the most common movement disorder; however, there is currently no satisfactory drug treatment. The neural mechanisms underlying ET remain unknown. One of the prevalent hypotheses is that ET is a result of a defective mechanism that normally dampens the natural oscillations of inferior olive (IO) neurons whose intrinsic oscillatory activity is attributed to the presence of low threshold calcium channels (LTCC). 1-Octanol is known to inhibit LTCC of olivary neurons and was found to reduce the tremor induced in rats with harmaline, an alkaloid known to hyperpolarize IO neurons increasing their tendency to fire rhythmically at rest. The aim of this study is to assess the effects of 1-octanol on ET in humans. This study is designed as a double-blind, placebo-controlled, single-dose trial in untreated patients with ET. Electromyography (EMG) and acclerometry are used to assess tremor before and after 1-octanol administration. The accepted daily intake (ADI) of 1-octanol (1 mg/kg/d) as a food additive will be given as a single dose. Toxicity from octanol will be monitored clinically and by liver function and electrolyte measurements.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Patients with essential tremor affecting the upper limbs who are 21 years of age or older. Patients who are not taking medications for essential tremor or any other medical condition for at least 2 weeks. Patients who have not consumed alcohol or cold medications containing alcohol for at least 24 hours prior to the day of the study. Women must not be pregnant or lactating. Women of childbearing age must use birth control while participating in this study. Patients must not have any neurological disease other than tremor (e.g., Parkinson's disease). Patients must not have evidence of thyroid, liver, kidney or chronic lung disease.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, United StatesOpen National Institute of Neurological Disorders and Stroke (NINDS) in Google Maps