Status:
COMPLETED
Octanol to Treat Essential Tremor
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Essential Tremor
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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...
Detailed Description
Essential tremor is a very common movement disorder affecting approximately 1.4% of the population. Response to medications such as beta blockers and mysoline may be only partial or be accompanied by ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 14 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.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00080366
Start Date
March 1 2004
End Date
March 1 2007
Last Update
April 4 2007
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892