Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467584
Status:
TERMINATED
Last Update Posted:
2014-05-20
First Post:
2007-04-26
Brief Title:
Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis indicated treatment unlikely effectiveslow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether aspirin is effective for treatment of fatigue caused by multiple sclerosis MS
Detailed Description:
Fatigue is the most common symptom of multiple sclerosis MS affecting up to 90 of people with the disease MS-related fatigue can be disabling even when other features of MS are mild It can interfere with physical activity memory and thinking social and family activities and ability to work Initial treatment consists of energy conservation techniques such as rest periods or naps but when these approaches fail doctors usually recommend a trial of medications Amantadine modafinil and other stimulants are commonly used but help only about half of those who try them It is unlikely that these drugs directly affect the cause of MS-related fatigue
It has been difficult to develop new drug therapies for MS-related fatigue because we do not fully understand its causes and do not have precise ways to measure it We rely on a persons self-report about their fatigue but individuals experience and report fatigue differently Recent research has shown that some fatigue aspects such as difficulty maintaining mental concentration cognitive fatigue and physical activity motor fatigue can be measured more precisely and require further study
We recently reported results from a study showing that people taking the equivalent of four regular aspirin tablets 1300 mg daily had reduced MS-related fatigue compared with placebo sugar pill The current proposal will attempt to confirm the benefit of aspirin in a larger group of people and to determine if the benefit is related to inflammation One hundred and thirty-five people with MS-related fatigue will participate at MS clinics at three Mayo Clinic sites Participants will complete questionnaires that ask about the severity and impact of their fatigue memory testing to assess cognitive fatigue and have blood testing to measure markers of inflammation At the Arizona site participants will also do strength testing in a motor laboratory to assess motor fatigue After obtaining two separate baseline evaluations the participants will be randomly assigned treatment such that one-third will receive 1300 mg per day of aspirin one-third will receive 162 mg per day of aspirin and one-third will receive a matching placebo All participants will then return to the clinic on two more occasions over the next eight weeks to repeat the questionnaires memory and strength testing blood tests and report any side-effects At the end of the study the results of one of the fatigue questionnaires will be analyzed to determine if aspirin significantly improved fatigue compared with the placebo The results of other questionnaires and the memory and strength testing will be analyzed as supportive evidence
If this study is successful it will provide strong scientific evidence that aspirin helps MS-related fatigue It will add an important new option for treatment of all MS patients that is also familiar inexpensive and has a good long-term safety record At the same time it will allow us to better understand the causes of MS-related fatigue and how to measure it more precisely This information will be extremely useful for development of other therapies in the future
It has been difficult to develop new drug therapies for MS-related fatigue because we do not fully understand its causes and do not have precise ways to measure it We rely on a persons self-report about their fatigue but individuals experience and report fatigue differently Recent research has shown that some fatigue aspects such as difficulty maintaining mental concentration cognitive fatigue and physical activity motor fatigue can be measured more precisely and require further study
We recently reported results from a study showing that people taking the equivalent of four regular aspirin tablets 1300 mg daily had reduced MS-related fatigue compared with placebo sugar pill The current proposal will attempt to confirm the benefit of aspirin in a larger group of people and to determine if the benefit is related to inflammation One hundred and thirty-five people with MS-related fatigue will participate at MS clinics at three Mayo Clinic sites Participants will complete questionnaires that ask about the severity and impact of their fatigue memory testing to assess cognitive fatigue and have blood testing to measure markers of inflammation At the Arizona site participants will also do strength testing in a motor laboratory to assess motor fatigue After obtaining two separate baseline evaluations the participants will be randomly assigned treatment such that one-third will receive 1300 mg per day of aspirin one-third will receive 162 mg per day of aspirin and one-third will receive a matching placebo All participants will then return to the clinic on two more occasions over the next eight weeks to repeat the questionnaires memory and strength testing blood tests and report any side-effects At the end of the study the results of one of the fatigue questionnaires will be analyzed to determine if aspirin significantly improved fatigue compared with the placebo The results of other questionnaires and the memory and strength testing will be analyzed as supportive evidence
If this study is successful it will provide strong scientific evidence that aspirin helps MS-related fatigue It will add an important new option for treatment of all MS patients that is also familiar inexpensive and has a good long-term safety record At the same time it will allow us to better understand the causes of MS-related fatigue and how to measure it more precisely This information will be extremely useful for development of other therapies in the future
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