Octanol to Treat Essential Tremor

NCT00080366 | Completed Phase 2

• 2 other identifiers: 04014704-N-0147
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of 1-octanol, a substance similar to alcohol but less intoxicating, for treating essential tremor. Essential tremor is an involuntary shaking, usually of the hands, for which there is no satisfactory treatment. It affects about 1.4 percent of the general U.S. population, with the figure climbing to nearly 4 percent among people over 40. Results of two previous NIH studies have shown 1-octanol to be promising as a potential new treatment. This study will test the effectiveness of 1-octanol on essential tremor at doses lower than those given previously. Patients 21 years old and older with essential tremor may be eligible for this study. Participants are admitted to the NIH Clinical Center for two treatment periods of 1 week each, with a 1-week break at home between treatments. Before beginning treatment, participants undergo a medical history, physical examination, blood and urine tests, and an electrocardiogram (EKG). In addition, tremors are measured using accelerometry, a procedure in which a small device, mounted on a piece of cardboard, is taped to the patient's hand for about 30 minutes. Patients are randomly assigned to one of two groups. One group takes 2 to 4 capsules of 1-octanol 3 times a day for 1 week, followed by a 1-week "washout" period (no treatment), and then 2 to 4 capsules of placebo 3 times a day for 1 week. Following the same dosage schedule, the second group takes placebo the first week, followed by the washout period and then 1-octanol treatment. Blood pressure and pulse are measured at 15, 30, and 60 minutes after the first dose of the day and then 3 times a day each day of hospitalization, EKG and blood draws are done every other day during hospitalization, and blood is drawn again 1 week after the end of the study. Patients evaluate their tremor daily according to a tremor scale and are also rated according to an alcohol intoxication scale.

Conditions

Essential Tremor

Keywords

Essential Tremor; Cross over Design; Accelerometry; Placebo; Alcohol Responsive; Double Blind; 1-Octanol

Outcome Measures

Primary Outcomes (1)

• Tremor as assessed by accelerometry.

Secondary Outcomes (1)

• Spiral drawing, subjective and clinical scoring.

Interventions

1-Octanol DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with a clinical diagnosis of essential tremor will participate in the study. Selection criterion is essential tremor with a history of ethanol responsiveness. Informed consent will be obtained by any of the co-investigators.
• Patients must be off any medications used to treat essential tremor such as mysoline or propranolol for at least 2 weeks. Patients must withhold ethanol and caffeine 24 hours prior to starting the treatment periods through the end of treatment periods, including alcohol or caffeine containing over the counter medications. Ethanol and caffeine consumption is allowed in the washout period.

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 medications that cannot be temporarily discontinued for the length of the study.
• 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.
• Patients under the age of 21.
• Asians and Pacific Islanders.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Bikson M, Ghai RS, Baraban SC, Durand DM. Modulation of burst frequency, duration, and amplitude in the zero-Ca(2+) model of epileptiform activity. J Neurophysiol. 1999 Nov;82(5):2262-70. doi: 10.1152/jn.1999.82.5.2262.

  PMID: 10561404 BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Interventions

1-Octanol

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Octanols; Fatty Alcohols; Alcohols; Organic Chemicals; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 27, 2004
• First Posted: March 29, 2004
• Study Start: March 1, 2004
• Study Completion: March 1, 2007
• Last Updated: April 4, 2007

Record last verified: 2007-03

Locations

US (1)