1-Octanol to Treat Essential Tremor
1-Octanol to Treat Essential Tremor
This study will evaluate the safety and effectiveness of the food additive 1-octanol for
 treating essential tremor. This disorder, which is an involuntary shaking, usually of the
 hands, has no satisfactory treatment. It affects more than one of every 100 people in the
 general population, with the figure climbing to nearly 4 in every hundred among people over
 40 years old. In animal studies, 1-octanol reduced chemically induced tremors in rats. This
 study will test the effects of the accepted daily intake of 1-octanol (1 milligram per
 kilogram of body weight) on essential tremor in humans.

 Patients with essential tremor 21 years old and older who wish to enroll in this study will
 undergo eligibility screening with a medical history and physical examination that includes
 tests for thyroid, liver and kidney problems. Participants will be randomly assigned to
 receive either 1-octanol or a placebo (an inactive substance). Patients in both groups will
 have an intravenous catheter (a thin, plastic tube) placed in an arm vein for collecting
 blood samples during the study. Those in the 1-octanol group will be given a 1-octanol
 capsule; the placebo group will receive a look-alike capsule containing no active ingredient.
 Neither the patient nor the doctor will know which patients are taking 1-octanol or placebo
 until the end of the study.

 Tremors will be measured once before the catheter is placed, every 15 minutes during the
 first 2 hours after taking the capsule, twice during the third hour (30 minutes apart), and
 once again after 5 hours. The tremors are measured using procedures called accelerometry and
 surface electromyography. For these procedures, electrodes are taped to the skin; needles are
 not used. Blood samples will be collected once before taking the capsule, every 15 minutes
 for the first hour and a half after taking the capsule and again at 2 hours, 4 hours and 5
 hours after taking the capsule. Vital signs (blood pressure, pulse, and respiratory rate)
 will be measured every 15 minutes during the first 2 hours of taking the capsule, every 30
 minutes during the third hour, and again at 4 hours and 5 hours.

 Participants will stay in the hospital overnight for observation and return after 3 days for
 a follow-up physical examination, including a blood test.
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.
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.