Essential TremorPhase 1NCT00001986
1-Octanol to Treat Essential Tremor
A Phase 1 study testing 1-Octanol in people with Essential Tremor, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Essential Tremor
- What is being tested?
- 1-Octanol
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Jan 2001
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients with essential tremor affecting the upper limbs who are 21 years of age or older.
Patients who are not taking medications for essential tremor or any other medical condition for at least 2 weeks.
Patients who have not consumed alcohol or cold medications containing alcohol for at least 24 hours prior to the day of the study.
Women must not be pregnant or lactating. Women of childbearing age must use birth control while participating in this study.
Patients must not have any neurological disease other than tremor (e.g., Parkinson's disease).
Patients must not have evidence of thyroid, liver, kidney or chronic lung disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Double-Blind, Placebo-Controlled, Single-Dose Trial of 1-Octanol in Essential Tremor
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.
Read more
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.
Read the 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 mg/kg/d) 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.
- Conditions
- Essential Tremor
- Being tested
- 1-Octanol
- Keywords
- Alcohol, Octanol, Treatment, Tremor
- Medical subject headings
- Essential Tremor, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-OctanolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJan 2000
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 12 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001986
- Sponsor's protocol ID
- 000062
- Other IDs
- 00-N-0062
- Status last verified
- Jan 2000
- First submitted
- 28 Jan 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Bal T, McCormick DA. Synchronized oscillations in the inferior olive are controlled by the hyperpolarization-activated cation current I(h). J Neurophysiol. 1997 Jun;77(6):3145-56. doi: 10.1152/jn.1997.77.6.3145.
PubMed 9212264Elble RJ. Animal models of action tremor. Mov Disord. 1998;13 Suppl 3:35-9. doi: 10.1002/mds.870131306.
PubMed 9827592
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Single-Dose Trial of 1-Octanol in Essential Tremor
- ClinicalTrials.gov ID
- NCT00001986
- Acronym / sponsor ID
- 000062
- Conditions
- Essential Tremor
- Keywords
- Alcohol, Octanol, Treatment, Tremor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 2000
- Study completion
- Jan 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 mg/kg/d) 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 design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-Octanol | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9212264Bal T, McCormick DA. Synchronized oscillations in the inferior olive are controlled by the hyperpolarization-activated cation current I(h). J Neurophysiol. 1997 Jun;77(6):3145-56. doi: 10.1152/jn.1997.77.6.3145.
- Background: PubMed 9827592Elble RJ. Animal models of action tremor. Mov Disord. 1998;13 Suppl 3:35-9. doi: 10.1002/mds.870131306.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1-Octanol in people with Essential Tremor, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001986, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.