1-Octanol to Treat Essential Tremor

NCT00016679 | Completed Phase 1

• 2 other identifiers: 01017801-N-0178
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Essential Tremor

Keywords

Pharmacokinetics; Metabolism; Toxicity; Side Effects; Essential Tremor; Tremor; Movement Disorder

Interventions

1-Octanol DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Lyon RC, McComb JA, Schreurs J, Goldstein DB. A relationship between alcohol intoxication and the disordering of brain membranes by a series of short-chain alcohols. J Pharmacol Exp Ther. 1981 Sep;218(3):669-75.

  PMID: 7264950 BACKGROUND

• Hellwig J, Jackh R. Differential prenatal toxicity of one straight-chain and five branched-chain primary alcohols in rats. Food Chem Toxicol. 1997 May;35(5):489-500. doi: 10.1016/s0278-6915(97)00007-0.

  PMID: 9216748 BACKGROUND

• Bal T, McCormick DA. Synchronized oscillations in the inferior olive are controlled by the hyperpolarization-activated cation current I(h). J Neurophysiol. 1997 Jun;77(6):3145-56. doi: 10.1152/jn.1997.77.6.3145.

  PMID: 9212264 BACKGROUND

MeSH Terms

Conditions

Essential Tremor; Tremor; Movement Disorders

Interventions

1-Octanol

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Octanols; Fatty Alcohols; Alcohols; Organic Chemicals; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 24, 2001
• First Posted: May 25, 2001
• Study Start: May 1, 2001
• Study Completion: March 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-03

Locations

US (1)