Essential TremorPhase 2NCT06312800
Acamprosate and Methazolamide for Essential Tremor
A Phase 2 study testing Acamprosate and Methazolamide in people with Essential Tremor, run by Henry Ford Health System at 1 site in United States.
Trial summary
This is an investigator initiated study is designed to evaluate the anti-tremor benefits of two marketed medications, methazolamide and acamprosate in subjects with a diagnosis of essential tremor (ET). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Acamprosate and Methazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2017
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bilateral, largely symmetric postural or kinetic tremor involving hands and forearms that is visible and persistent. Subjects need to meet a FTMRS. Part A motor score of at least 2 ("Moderate amplitude, 0.5-1 cm, may be intermittent") in the dominant upper limb for action or postural tremor (or both).
- additional tremor (head, voice, or lower extremity) may also be present but in the absence of abnormal posturing so as to suggest the diagnosis of dystonia.
Who cannot join
- other abnormal neurologic signs
- the presence of known causes of enhanced physiologic tremor, including current or recent exposure to drugs known to cause or exacerbate tremor, or the presence of a drug -withdrawal state
- historical or clinical evidence of psychogenic tremor
- convincing evidence of sudden onset or other evidence of stepwise deterioration
- primary orthostatic tremor
- isolated position-specific or task-specific tremors, including occupational tremors and primary writing tremor
Show all 10Show fewer
- tremor possibly or probably due to other neurological disorders (such as Parkinson's disease, cerebellar degeneration, and hyperthyroidism)
- prior brain surgery (including deep brain stimulation of Gamma Knife treatment) for thalamotomy
- known allergy to the study medications
- clinically significant liver, kidney, or cardiac abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
About this study
Official title: Acamprosate and Methazolamide for Essential Tremor: a Randomized Clinical Trial
This is an investigator initiated study is designed to evaluate the anti-tremor benefits of two marketed medications, methazolamide and acamprosate in subjects with a diagnosis of essential tremor (ET).
Read the detailed description
This is an investigator-initiated study is designed to evaluate the anti-tremor benefits of two marketed medications, methazolamide and acamprosate in subjects with a diagnosis of essential tremor (ET). Methazolamide is approved by the FDA to treat glaucoma. Acamprosate is approved by the FDA and used in the treatment of alcoholism. Some subjects using these medications for those indications incidentally reported that they had improvement in their essential tremor symptoms.
The primary objective of this study is the change in the upper extremity tremor scores assessed by one of the tremor rating scales (FTMRS) compared to baseline. This scale has been used in previous reported studies. Secondary objectives will be to evaluate the change in the ratings on several scales between placebo and study medication treatment. Additionally, tremor amplitude will be measured with device called Kinesia HomeView. This has a sensor unit that is slipped over a finger and transmits information to a nearby computer. This device has been used by our staff in other clinical studies at our site to evaluate tremor symptoms.
The study is a double blind, parallel design with three separate treatment arms, each 3 weeks long . One arm is placebo, the other two are conventional dosing of either acamprosate (333 mg tablets TID) or methazolamide (50 mg tablets TID). Subjects who have ET and meet criteria will be randomized in varied order to undergo all three treatments. There will be a one-week washout period between arms of study treatments where subject are not on any study medication. Subjects who qualify will be titrated on every three days up to a final dose of one table,t three times a day at mealtimes by day 7. They will then be evaluated after two weeks and three weeks on this dose.
There are 7 visits for the study. Consent will be reviewed and signed at the beginning of visit one. All study visits include vital sign assessment, neurological exam, suicidality, tremor rating scales and Kinesia recoding. Quality of life questionnaire will be completed weekly after start. Visit one will also include collecting information on medical history, medication history and current medication. A physical exam will be done on visit one and at the end of the study. For qualifying patients, study medication will be dispensed at the end of visit one and instructions provided for titrating. Medication will be collected and counted at each visit, each arm will last for 3 weeks, with subject ET symptom assessment at week 2 and 3. After completion of week 3 assessments, all study medication will be returned, and they will change dosing to the next assigned arm where the same assessment cycle is undergone. Study medication and directions will be provided with directives to start dosing after one week wash out. After trial arm 3, subject trial participation is completed. Adverse events are assessed weekly from starting trial medication at visit one until one week after end of trial.
- Conditions
- Essential Tremor
- Being tested
- Acamprosate, Placebo, Methazolamide
- Keywords
- Essential Tremor
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcamprosateDrug
Randomized allocation of treatments will guide the dispensation of treatments in one of 6 possible sequences--ex, M (methazolamide)- P(placebo)-A (Acamprosate); or PAM or MAP or PMA or AMP or APM. Biostatistician will devise medication randomization strategies and investigators and staff will be blinded.
PlaceboDrug
Randomized allocation of treatments will guide the dispensation of treatments in one of 6 possible sequences--ex, M (methazolamide)- P(placebo)-A (Acamprosate); or PAM or MAP or PMA or AMP or APM. Biostatistician will devise medication randomization strategies and investigators and staff will be blinded.
MethazolamideDrug
Randomized allocation of treatments will guide the dispensation of treatments in one of 6 possible sequences--ex, M (methazolamide)- P(placebo)-A (Acamprosate); or PAM or MAP or PMA or AMP or APM. Biostatistician will devise medication randomization strategies and investigators and staff will be blinded.
| Study group | Role | What they receive |
|---|---|---|
| Acamprosate | Experimental | Commercially available Acamprosate 333 mg tablets will be administered three times daily. Subjects will be started with one tablet with breakfast for 3 days, then one tablet with breakfast and dinner for 3 days, then one tablet 3 times a day for the next 15 days. Intervention order of medication trials will be determined by biostatistician. Receives: Drug: Acamprosate |
| Placebo | Active comparator | Placebo tablets are not available from the manufacturer for either of these drugs which are marketed as white tablets about the size of an aspirin tablet. Custom made placebo tablets will be purchased that are about that size. While not ideal , the extent of disguising the drug identity should be adequate with this. The placebo tablets will be administered three times daily. Subjects will be started with one tablet with breakfast for 3 days, then one tablet with breakfast and dinner for 3 days, then one tablet 3 times a day for the next 15 days. Intervention order of medication trials will be determined by biostatistician Receives: Drug: Placebo |
| Methazolamide | Experimental | Commercially available methazolamide 50 mg tablets will be administered three times daily. Subjects will be started with one tablet with breakfast for 3 days, then one tablet with breakfast and dinner for 3 days, then one tablet 3 times a day for the next 15 days. Intervention order of medication trials will be determined by biostatistician Receives: Drug: Methazolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fahn-Talosa-Marin rating scale (FTMRS) Part A
Comparison of placebo to each of the two medications for the sum of upper extremity postural and action tremor scores from the Fahn-Talosa-Marin rating scale (FTMRS).
The Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (FTM) has been used for essential tremor (ET), but its anchors for ratings from 0 to 4 of upper limb tremor are probably too low for patients with severe tremor (tremor amplitude >4 cm; grade 4).
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study startMar 2016 (estimated)
- Primary completionJun 2017
- Study completionDec 2017
Why it stopped: Study was never initiated.
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.
- More trials run by Henry Ford Health SystemThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter LeWitt MD, Henry Ford Health System
- Investigators
- Peter LeWitt, M.D., Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312800
- Sponsor's protocol ID
- LeWitt02
- Status last verified
- Sep 2024
- First submitted
- 13 Jul 2015
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acamprosate and Methazolamide for Essential Tremor: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06312800
- Acronym / sponsor ID
- LeWitt02
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Mar 2016 (estimated)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Mar 2024 (actual)
- 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 is an investigator initiated study is designed to evaluate the anti-tremor benefits of two marketed medications, methazolamide and acamprosate in subjects with a diagnosis of essential tremor (ET).
Detailed description
This is an investigator-initiated study is designed to evaluate the anti-tremor benefits of two marketed medications, methazolamide and acamprosate in subjects with a diagnosis of essential tremor (ET). Methazolamide is approved by the FDA to treat glaucoma. Acamprosate is approved by the FDA and used in the treatment of alcoholism. Some subjects using these medications for those indications incidentally reported that they had improvement in their essential tremor symptoms.
The primary objective of this study is the change in the upper extremity tremor scores assessed by one of the tremor rating scales (FTMRS) compared to baseline. This scale has been used in previous reported studies. Secondary objectives will be to evaluate the change in the ratings on several scales between placebo and study medication treatment. Additionally, tremor amplitude will be measured with device called Kinesia HomeView. This has a sensor unit that is slipped over a finger and transmits information to a nearby computer. This device has been used by our staff in other clinical studies at our site to evaluate tremor symptoms.
The study is a double blind, parallel design with three separate treatment arms, each 3 weeks long . One arm is placebo, the other two are conventional dosing of either acamprosate (333 mg tablets TID) or methazolamide (50 mg tablets TID). Subjects who have ET and meet criteria will be randomized in varied order to undergo all three treatments. There will be a one-week washout period between arms of study treatments where subject are not on any study medication. Subjects who qualify will be titrated on every three days up to a final dose of one table,t three times a day at mealtimes by day 7. They will then be evaluated after two weeks and three weeks on this dose.
There are 7 visits for the study. Consent will be reviewed and signed at the beginning of visit one. All study visits include vital sign assessment, neurological exam, suicidality, tremor rating scales and Kinesia recoding. Quality of life questionnaire will be completed weekly after start. Visit one will also include collecting information on medical history, medication history and current medication. A physical exam will be done on visit one and at the end of the study. For qualifying patients, study medication will be dispensed at the end of visit one and instructions provided for titrating. Medication will be collected and counted at each visit, each arm will last for 3 weeks, with subject ET symptom assessment at week 2 and 3. After completion of week 3 assessments, all study medication will be returned, and they will change dosing to the next assigned arm where the same assessment cycle is undergone. Study medication and directions will be provided with directives to start dosing after one week wash out. After trial arm 3, subject trial participation is completed. Adverse events are assessed weekly from starting trial medication at visit one until one week after end of trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acamprosate | Experimental | Drug: AcamprosateCommercially available Acamprosate 333 mg tablets will be administered three times daily. Subjects will be started with one tablet with breakfast for 3 days, then one tablet with breakfast and dinner for 3 days, then one tablet 3 times a day for the next 15 days. Intervention order of medication trials will be determined by biostatistician. |
| Placebo | Active comparator | Drug: PlaceboPlacebo tablets are not available from the manufacturer for either of these drugs which are marketed as white tablets about the size of an aspirin tablet. Custom made placebo tablets will be purchased that are about that size. While not ideal , the extent of disguising the drug identity should be adequate with this. The placebo tablets will be administered three times daily. Subjects will be started with one tablet with breakfast for 3 days, then one tablet with breakfast and dinner for 3 days, then one tablet 3 times a day for the next 15 days. Intervention order of medication trials will be determined by biostatistician |
| Methazolamide | Experimental | Drug: MethazolamideCommercially available methazolamide 50 mg tablets will be administered three times daily. Subjects will be started with one tablet with breakfast for 3 days, then one tablet with breakfast and dinner for 3 days, then one tablet 3 times a day for the next 15 days. Intervention order of medication trials will be determined by biostatistician |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- bilateral, largely symmetric postural or kinetic tremor involving hands and forearms that is visible and persistent. Subjects need to meet a FTMRS. Part A motor score of at least 2 ("Moderate amplitude, 0.5-1 cm, may be intermittent") in the dominant upper limb for action or postural tremor (or both).
- additional tremor (head, voice, or lower extremity) may also be present but in the absence of abnormal posturing so as to suggest the diagnosis of dystonia.
Key exclusion criteria (10 listed)
- other abnormal neurologic signs
- the presence of known causes of enhanced physiologic tremor, including current or recent exposure to drugs known to cause or exacerbate tremor, or the presence of a drug -withdrawal state
- historical or clinical evidence of psychogenic tremor
- convincing evidence of sudden onset or other evidence of stepwise deterioration
- primary orthostatic tremor
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 |
|---|---|---|
| AcamprosateRandomized allocation of treatments will guide the dispensation of treatments in one of 6 possible sequences--ex, M (methazolamide)- P(placebo)-A (Acamprosate); or PAM or MAP or PMA or AMP or APM. Biostatistician will devise medication randomization strategies and investigators and staff will be blinded. | Drug | Acamprosate |
| PlaceboRandomized allocation of treatments will guide the dispensation of treatments in one of 6 possible sequences--ex, M (methazolamide)- P(placebo)-A (Acamprosate); or PAM or MAP or PMA or AMP or APM. Biostatistician will devise medication randomization strategies and investigators and staff will be blinded. | Drug | Placebo |
| MethazolamideRandomized allocation of treatments will guide the dispensation of treatments in one of 6 possible sequences--ex, M (methazolamide)- P(placebo)-A (Acamprosate); or PAM or MAP or PMA or AMP or APM. Biostatistician will devise medication randomization strategies and investigators and staff will be blinded. | Drug | Methazolamide |
Primary outcome
Fahn-Talosa-Marin rating scale (FTMRS) Part A
Time frame: 11 weeks
Comparison of placebo to each of the two medications for the sum of upper extremity postural and action tremor scores from the Fahn-Talosa-Marin rating scale (FTMRS). The Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (FTM) has been used for essential tremor (ET), but its anchors for ratings from 0 to 4 of upper limb tremor are probably too low for patients with severe tremor (tremor amplitude >4 cm; grade 4).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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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.
Peter LeWitt, M.D. principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acamprosate and Methazolamide in people with Essential Tremor, run by Henry Ford Health 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 2 inclusion and 10 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: withdrawn, as of the sponsor's last update on 25 Sep 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Fahn-Talosa-Marin rating scale (FTMRS) Part A (time frame: 11 weeks). 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 25 Sep 2024.