Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001986
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-28
Brief Title:
1-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:
Double-Blind Placebo-Controlled Single-Dose Trial of 1-Octanol in Essential Tremor
Status:
COMPLETED
Status Verified Date:
2000-01
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 safety and effectiveness of the food additive 1-octanol for treating essential tremor This disorder which is an involuntary shaking usually of the hands has no satisfactory treatment It affects more than one of every 100 people in the general population with the figure climbing to nearly 4 in every hundred among people over 40 years old In animal studies 1-octanol reduced chemically induced tremors in rats This study will test the effects of the accepted daily intake of 1-octanol 1 milligram per kilogram of body weight on essential tremor in humans
Patients with essential tremor 21 years old and older who wish to enroll in this study will undergo eligibility screening with a medical history and physical examination that includes tests for thyroid liver and kidney problems Participants will be randomly assigned to receive either 1-octanol or a placebo an inactive substance Patients in both groups will have an intravenous catheter a thin plastic tube placed in an arm vein for collecting blood samples during the study Those in the 1-octanol group will be given a 1-octanol capsule the placebo group will receive a look-alike capsule containing no active ingredient Neither the patient nor the doctor will know which patients are taking 1-octanol or placebo until the end of the study
Tremors will be measured once before the catheter is placed every 15 minutes during the first 2 hours after taking the capsule twice during the third hour 30 minutes apart and once again after 5 hours The tremors are measured using procedures called accelerometry and surface electromyography For these procedures electrodes are taped to the skin needles are not used Blood samples will be collected once before taking the capsule every 15 minutes for the first hour and a half after taking the capsule and again at 2 hours 4 hours and 5 hours after taking the capsule Vital signs blood pressure pulse and respiratory rate will be measured every 15 minutes during the first 2 hours of taking the capsule every 30 minutes during the third hour and again at 4 hours and 5 hours
Participants will stay in the hospital overnight for observation and return after 3 days for a follow-up physical examination including a blood test
Patients with essential tremor 21 years old and older who wish to enroll in this study will undergo eligibility screening with a medical history and physical examination that includes tests for thyroid liver and kidney problems Participants will be randomly assigned to receive either 1-octanol or a placebo an inactive substance Patients in both groups will have an intravenous catheter a thin plastic tube placed in an arm vein for collecting blood samples during the study Those in the 1-octanol group will be given a 1-octanol capsule the placebo group will receive a look-alike capsule containing no active ingredient Neither the patient nor the doctor will know which patients are taking 1-octanol or placebo until the end of the study
Tremors will be measured once before the catheter is placed every 15 minutes during the first 2 hours after taking the capsule twice during the third hour 30 minutes apart and once again after 5 hours The tremors are measured using procedures called accelerometry and surface electromyography For these procedures electrodes are taped to the skin needles are not used Blood samples will be collected once before taking the capsule every 15 minutes for the first hour and a half after taking the capsule and again at 2 hours 4 hours and 5 hours after taking the capsule Vital signs blood pressure pulse and respiratory rate will be measured every 15 minutes during the first 2 hours of taking the capsule every 30 minutes during the third hour and again at 4 hours and 5 hours
Participants will stay in the hospital overnight for observation and return after 3 days for a follow-up physical examination including a blood test
Detailed Description:
Essential tremor ET is the most common movement disorder however there is currently no satisfactory drug treatment The neural mechanisms underlying ET remain unknown One of the prevalent hypotheses is that ET is a result of a defective mechanism that normally dampens the natural oscillations of inferior olive IO neurons whose intrinsic oscillatory activity is attributed to the presence of low threshold calcium channels LTCC 1-Octanol is known to inhibit LTCC of olivary neurons and was found to reduce the tremor induced in rats with harmaline an alkaloid known to hyperpolarize IO neurons increasing their tendency to fire rhythmically at rest The aim of this study is to assess the effects of 1-octanol on ET in humans This study is designed as a double-blind placebo-controlled single-dose trial in untreated patients with ET Electromyography EMG and acclerometry are used to assess tremor before and after 1-octanol administration The accepted daily intake ADI of 1-octanol 1 mgkgd as a food additive will be given as a single dose Toxicity from octanol will be monitored clinically and by liver function and electrolyte measurements
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 |
|---|---|---|---|
| 00-N-0062 | None | None | None |