Essential TremorPhase 4NCT00439699
A Pilot Clinical Trial Of Memantine for Essential Tremor
A Phase 4 study testing Memantine in people with Essential Tremor, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to obtain information on whether or not the medication Memantine reduces tremor in persons with essential tremor and is well-tolerated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Memantine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Subject diagnosed with essential tremor affecting both upper extremities.
- Subject has been diagnosed for at least one year with tremor that is troublesome, so that improvement of tremor would improve the quality of life.
- Subject has tremor with a tremor rating scale severity of 2 to 4 in one or both upper extremities in the tremor rating scale during posture and/or kinesis.
- Subject has not had satisfactory tremor response to at least one anti-tremor medication.
- Subject is able to comply with all testing and follow-up visit requirements.
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- Subject is able to abstain from alcohol for at least 12 hours prior to each Study Visit and from caffeinated beverages on the day of the Visit.
- Subject has voluntarily signed an informed consent in accordance with institutional policies.
- Subject is either
- Not taking medication for Essential Tremor and has not done so for at least 28 days prior to Visit 1.
- Taking medication for Essential Tremor and has been taking a stable dose so for at least 28 days prior to Visit 1.
Who cannot join
- Subject has progressive neurological disease other than Essential Tremor.
- Subject has history of alcoholism or drug abuse within the past year.
- Subject has history of mania, bipolar depressive disorder, schizophrenia, or other major psychiatric disorder.
- Subject drinks more than 2 glasses of wine or equivalent per day in last 30 days.
- Subject has received botulinum injection of the upper extremities in the past 6 months.
- Subject is currently using investigational device.
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- Subject has taken an investigational drug within a clearance duration of 5 times the half-life of the investigational drug.
- Subject is pregnant or a female of childbearing potential not using adequate contraception.
- Subject has a medical condition likely to result in hospitalization.
- Known allergy to memantine or amantadine.
- Taking medication that alkalinizes the urine, such as carbonic anhydrase inhibitor or sodium bicarbonate.
- Any disorder or condition that may interfere with the absorption, the distribution, or excretion of drugs.
- Taking medication known to cause postural tremor, that in the clinical judgement of the investigator is contributing to the subject's tremor.
- Receiving deep brain stimulation within two weeks prior to Visit 1 or has potential need for deep brain stimulation during the study.
- Has received ablative thalamotomy or gamma knife thalamotomy within six months of study onset.
- Tremor potentially due to head trauma, hyperthyroidism, cerebrovascular disease, multiple sclerosis, polyneuropathy, or family history of Fragile X syndrome.
- Known renal disease with creatinine level outside normal range.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles
Los Angeles, California, 90073
About this study
Official title: A Pilot Clinical Trial of Memantine for Essential Tremor
The purpose of this study is to obtain information on whether or not the medication Memantine reduces tremor in persons with essential tremor and is well-tolerated.
Read the detailed description
Background: Essential tremor (ET) is the most common movement disorder but has relatively few effective and tolerated therapies. Tremor in ET is believed to be generated by a central oscillator, the inferior olivary nucleus. Membrane potentials in neurons of this nucleus oscillate at tremor frequency. Evidence indicates that the ability of this nucleus to produce tremor is medicated by glutamate acting on the NMDA receptor. As NMDA receptor antagonists suppress tremor, it is suggested that memantine, a low affinity NMDA antagonist, will be effective for essential tremor.
Objective: To assess the efficacy, safety and stability of response to memantine in a pilot single-site feasibility rising-dose trial in the treatment of essential tremor.
Method: Subjects with bilateral upper extremity essential tremor, on no essential tremor therapy, or on a stable-dose therapy, will have laboratory tests and EKG tests at a screening visit. Eligible subjects will have baseline tremor assessments with standardized rating scales. The tremor will be videotaped. In the first titration step, all subjects will take memantine at the dose of 5 mg/day for 2 weeks, then 5 mg twice a day for another 2 weeks, and tremor again assessed. In the second titration step the dose will similarly be raised to 20 mg/day, taken as 10 mg twice a day, and tremor assessed 4 weeks after the last tremor assessment. In the third titration step, the dose will be raised to 30 mg/day, taken as 15 mg twice a day, and tremor assessed at the conclusion of the third titration step. In the fourth titration step, the dose will be raised to 40 mg/day, taken as 20 mg twice a day, and tremor assessed at the conclusion of the fourth titration step. The dose will be adjusted downwards if titration is not tolerated. Subjects who achieve a clinically meaningful tremor reduction will enter a 12-week extension study assessing the stability of the tremor response.
Data analysis: Subjects will be recruited according to a two-part Gehan design. A "responder" is defined as a 30% reduction in the tremor score. To assess whether memantine has a potential responder rate of 30 percent, 9 subjects will be recruited in the first phase. If at least one subject is a responder, another 16 subjects will be recruited to estimate the actual responder rate with a standard error of 10%.
Conclusions: If memantine is effective in suppressing tremor, it would be welcomed by patients and the movement disorders community as a well-tolerated new treatment for essential tremor.
- Conditions
- Essential Tremor
- Being tested
- Memantine
- Keywords
- Essential Tremor, Memantine, Clinical Trial
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Mematine administration
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Experimental | Tremor reduction Receives: Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of tremor at the end of the dose adjustment phase compared to baseline
Measured: Six months
Secondary outcomes (2)
Quality of Life.
Measured: Six months
Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Ralph M. Parsons Foundation, Forest Laboratories
- Responsible party
- Principal investigator, Adrian Handforth, MD, VA Greater Los Angeles Healthcare System
- Investigators
- Adrian Handforth, M.D., Principal investigator, Veteran Affairs Greater Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439699
- Sponsor's protocol ID
- 0033
- Status last verified
- Jun 2012
- First submitted
- 22 Feb 2007
- Last updated
- 22 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of Memantine for Essential Tremor
- ClinicalTrials.gov ID
- NCT00439699
- Acronym / sponsor ID
- 0033
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor, Memantine, Clinical Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- Ralph M. Parsons Foundation, Forest Laboratories
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Feb 2007 (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.
The purpose of this study is to obtain information on whether or not the medication Memantine reduces tremor in persons with essential tremor and is well-tolerated.
Detailed description
Background: Essential tremor (ET) is the most common movement disorder but has relatively few effective and tolerated therapies. Tremor in ET is believed to be generated by a central oscillator, the inferior olivary nucleus. Membrane potentials in neurons of this nucleus oscillate at tremor frequency. Evidence indicates that the ability of this nucleus to produce tremor is medicated by glutamate acting on the NMDA receptor. As NMDA receptor antagonists suppress tremor, it is suggested that memantine, a low affinity NMDA antagonist, will be effective for essential tremor.
Objective: To assess the efficacy, safety and stability of response to memantine in a pilot single-site feasibility rising-dose trial in the treatment of essential tremor.
Method: Subjects with bilateral upper extremity essential tremor, on no essential tremor therapy, or on a stable-dose therapy, will have laboratory tests and EKG tests at a screening visit. Eligible subjects will have baseline tremor assessments with standardized rating scales. The tremor will be videotaped. In the first titration step, all subjects will take memantine at the dose of 5 mg/day for 2 weeks, then 5 mg twice a day for another 2 weeks, and tremor again assessed. In the second titration step the dose will similarly be raised to 20 mg/day, taken as 10 mg twice a day, and tremor assessed 4 weeks after the last tremor assessment. In the third titration step, the dose will be raised to 30 mg/day, taken as 15 mg twice a day, and tremor assessed at the conclusion of the third titration step. In the fourth titration step, the dose will be raised to 40 mg/day, taken as 20 mg twice a day, and tremor assessed at the conclusion of the fourth titration step. The dose will be adjusted downwards if titration is not tolerated. Subjects who achieve a clinically meaningful tremor reduction will enter a 12-week extension study assessing the stability of the tremor response.
Data analysis: Subjects will be recruited according to a two-part Gehan design. A "responder" is defined as a 30% reduction in the tremor score. To assess whether memantine has a potential responder rate of 30 percent, 9 subjects will be recruited in the first phase. If at least one subject is a responder, another 16 subjects will be recruited to estimate the actual responder rate with a standard error of 10%.
Conclusions: If memantine is effective in suppressing tremor, it would be welcomed by patients and the movement disorders community as a well-tolerated new treatment for essential tremor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memantine | Experimental | Drug: MemantineTremor reduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 or older
- Subject diagnosed with essential tremor affecting both upper extremities.
- Subject has been diagnosed for at least one year with tremor that is troublesome, so that improvement of tremor would improve the quality of life.
- Subject has tremor with a tremor rating scale severity of 2 to 4 in one or both upper extremities in the tremor rating scale during posture and/or kinesis.
- Subject has not had satisfactory tremor response to at least one anti-tremor medication.
Key exclusion criteria (17 listed)
- Subject has progressive neurological disease other than Essential Tremor.
- Subject has history of alcoholism or drug abuse within the past year.
- Subject has history of mania, bipolar depressive disorder, schizophrenia, or other major psychiatric disorder.
- Subject drinks more than 2 glasses of wine or equivalent per day in last 30 days.
- Subject has received botulinum injection of the upper extremities in the past 6 months.
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 |
|---|---|---|
| MemantineMematine administration | Drug | Memantine |
Primary outcome
The degree of tremor at the end of the dose adjustment phase compared to baseline
Time frame: Six months
2 secondary outcomes
Quality of Life.
Time frame: Six months
Degree of tremor at the end of the extension phase compared to the beginning of the extension phase.
Time frame: Six months
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 22 Jun 2012.
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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.
Adrian Handforth, M.D. principal investigator
Veteran Affairs Greater Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Memantine in people with Essential Tremor, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
The degree of tremor at the end of the dose adjustment phase compared to baseline (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2012.