Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT06312800 |
| Other study ID # |
LeWitt02 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
March 2016 |
| Est. completion date |
December 2017 |
Study information
| Verified date |
March 2024 |
| Source |
Henry Ford Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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).
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 (FMTRS) 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 near by 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 tablet 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 assessement 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.
