Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-28 @ 7:46 AM
Study NCT ID:
NCT00080366
Status:
COMPLETED
Last Update Posted:
2007-04-04
First Post:
2004-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Octanol to Treat Essential Tremor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020329', 'term': 'Essential Tremor'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020003', 'term': '1-Octanol'}], 'ancestors': [{'id': 'D000442', 'term': 'Octanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-03'}, 'lastUpdateSubmitDate': '2007-04-03', 'studyFirstSubmitDate': '2004-03-27', 'studyFirstSubmitQcDate': '2004-03-26', 'lastUpdatePostDateStruct': {'date': '2007-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tremor as assessed by accelerometry.'}], 'secondaryOutcomes': [{'measure': 'Spiral drawing, subjective and clinical scoring.'}]}, 'conditionsModule': {'keywords': ['Essential Tremor', 'Cross over Design', 'Accelerometry', 'Placebo', 'Alcohol Responsive', 'Double Blind', '1-Octanol'], 'conditions': ['Essential Tremor']}, 'referencesModule': {'references': [{'pmid': '10561404', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.\n\nPatients 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.', 'detailedDescription': '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 intolerable side effects. Roughly 80% of patients have significant tremor reduction from? ethanol although daily use of this as a treatment has potentially serious social and legal consequences. The leading hypothesis for the pathophysiology of essential tremor is the unmasking of spontaneous oscillation of neurons in the inferior olive. Both ethanol and 1-octanol have been shown to reduce these spontaneous oscillations in a animal model of essential tremor; however, 1-octanol does this at a dose much lower than an intoxicating dose suggesting that it may be useful in the treatment of essential tremor. Two pilot studies with 1-octanol in patients with essential tremor suggested it was both efficacious and safe.\n\nObjectives: The aim of the present study is to further assess efficacy of 1-octanol in essential tremor in a double-blinded, placebo-controlled study.\n\nStudy population: Patients with alcohol-responsive essential tremor.\n\nDesign: Double-blind, placebo-controlled two-period cross-over design.\n\nOutcome parameters: Primary outcome parameter is tremor as assessed by accelerometry, secondary outcome measures are spiral drawing, subjective and clinical scoring.\n\nEstimate of the outcome: 1-octanol at the dose of 32mg/kg three times a day will significantly improve tremor in patients with alcohol-responsive essential tremor.\n\nAnticipated risks and benefits: Besides the unusual taste, there are no anticipated risks associated with 1-octanol ingestion. Patients may experience an improvement of their tremor.\n\nPotential meaning for the field: Better treatment of essential tremor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\n 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.\n\nPatients 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.\n\nEXCLUSION CRITERIA:\n\nPatients with abnormalities on neurologic exam other than tremor.\n\nPatients with a history of chronic alcohol dependence.\n\nPatients with chronic medical conditions such as renal failure, hepatic failure and chronic lung disease.\n\nPatients on other medications that cannot be temporarily discontinued for the length of the study.\n\nPatients, who, for moral or religious reasons, do not wish to take a potentially intoxicating drug.\n\nPatients with abnormalities on their baseline screening laboratory tests.\n\nWomen who are pregnant or lactating.\n\nPatients under the age of 21.\n\nAsians and Pacific Islanders.'}, 'identificationModule': {'nctId': 'NCT00080366', 'briefTitle': 'Octanol to Treat Essential Tremor', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Treatment Efficacy of 1-Octanol Compared to Placebo in Adults With Essential Tremor', 'orgStudyIdInfo': {'id': '040147'}, 'secondaryIdInfos': [{'id': '04-N-0147'}]}, 'armsInterventionsModule': {'interventions': [{'name': '1-Octanol', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}}}}