Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312800
Status:
WITHDRAWN
Last Update Posted:
2024-03-15
First Post:
2015-07-13
Brief Title:
Acamprosate and Methazolamide for Essential Tremor
Sponsor:
Henry Ford Health System
Organization:
Henry Ford Health System
Study Overview
Official Title:
Acamprosate and Methazolamide for Essential Tremor a Randomized Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was never initiated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 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 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
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 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 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 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