1-Octanol to Treat Essential Tremor

Completed · Phase 1

Conditions studied: Essential Tremor

In brief

This study will determine the optimal dose of 1-octanol that will safely reduce tremors in patients with essential tremor-a disorder in which the hands, and sometimes the head, shake involuntarily. Current treatments may be ineffective or produce unwanted side effects. Ethanol (the chemical in beer and wine that causes intoxication) reduces tremor in many patients, but patients generally don't use it regularly because it interferes with daily activities. Laboratory studies show that 1-octanol, a drug that is similar to ethanol, may have the same beneficial effect on tremors with less likelihood of intoxication. Patients 21 years of age and older with essential tremor may be eligible for this 10-day study. Candidates will be evaluated with a neurological examination, blood tests, urinalysis and electrocardiogram (EKG). Those enrolled will be admitted to the hospital for 4 days for 1-octanol administration and monitoring. On day 1, patients will have a medical history and physical examination. A catheter (a thin plastic tube) will be placed in a vein of the forearm for sampling blood. Patients will take one 1-octanol capsule (at one of seven doses) by mouth and will be monitored for tremors and drug side effects. Blood will be sampled periodically in the first 3 hours to determine 1-octanol blood levels. On days 2 and 3, patients will be monitored for additional side effects. On days 3 and 4, laboratory tests (blood and urine) will be done to evaluate liver and kidney function. On day 4, the catheter will be removed and the patient will be discharged from the hospital. A follow-up visit will be scheduled 1 week after discharge for a physical examination and blood, urine and EKG tests.

Key facts

Study ID: NCT00016679
Run by: National Institute of Neurological Disorders and Stroke (NINDS)
People needed: 42
Starts: 2001-05-01
Expected to finish: 2004-03-01
Last updated by the study team: 2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with essential tremor with a history or ethanol responsiveness.
Patients must be off any medications used to treat essential tremor such as mysoline or propranalol for at least 2 weeks.
Patients must withhold ethanol and caffeine from 24 hours prior to starting the study until study termination (10 days).

You may not qualify if…

Patients with abnormalities on neurologic exam other than tremor.
Patients with a history of chronic alcohol dependence.
Patients with chronic medical conditions such as renal failure, hepatic failure and chronic lung disease.
Patients on other chronic medications that cannot be temporarily discontinued for the length of the study (10 days).
Patients, who for moral or religious reasons do not wish to take a potentially intoxicating drug.
Patients with abnormalities on their baseline screening laboratory tests.
Women who are pregnant or lactating.
People of Asian decent who may differ pharmocogenetically with respect to alcohol and aldehyde dehydrogenase and may have increased sensitivity to alcohols and their metabolites

Where it is running

National Institute of Neurological Disorders and Stroke (NINDS) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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