Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080366
Status:
COMPLETED
Last Update Posted:
2007-04-04
First Post:
2004-03-27
Brief Title:
Octanol to Treat Essential Tremor
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment Efficacy of 1-Octanol Compared to Placebo in Adults With Essential Tremor
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 14 percent of the general US 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 patients 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
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 patients 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
Detailed Description:
Essential tremor is a very common movement disorder affecting approximately 14 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
Objectives The aim of the present study is to further assess efficacy of 1-octanol in essential tremor in a double-blinded placebo-controlled study
Study population Patients with alcohol-responsive essential tremor
Design Double-blind placebo-controlled two-period cross-over design
Outcome parameters Primary outcome parameter is tremor as assessed by accelerometry secondary outcome measures are spiral drawing subjective and clinical scoring
Estimate of the outcome 1-octanol at the dose of 32mgkg three times a day will significantly improve tremor in patients with alcohol-responsive essential tremor
Anticipated 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
Potential meaning for the field Better treatment of essential tremor
Objectives The aim of the present study is to further assess efficacy of 1-octanol in essential tremor in a double-blinded placebo-controlled study
Study population Patients with alcohol-responsive essential tremor
Design Double-blind placebo-controlled two-period cross-over design
Outcome parameters Primary outcome parameter is tremor as assessed by accelerometry secondary outcome measures are spiral drawing subjective and clinical scoring
Estimate of the outcome 1-octanol at the dose of 32mgkg three times a day will significantly improve tremor in patients with alcohol-responsive essential tremor
Anticipated 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
Potential meaning for the field Better treatment of essential tremor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-N-0147 | None | None | None |