Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

This study has been terminated.
(Slow accrual, and interim analysis indicated the treatment was less effective than planned.)
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
Dean Wingerchuk, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00467584
First received: April 26, 2007
Last updated: January 17, 2014
Last verified: January 2014

April 26, 2007
January 17, 2014
March 2007
September 2013   (final data collection date for primary outcome measure)
Modified Fatigue Impact Scale score at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Modified Fatigue Impact Scale score at 8 weeks [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT00467584 on ClinicalTrials.gov Archive Site
  • Visual Analog Scale score at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Cognitive fatigue measure at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Motor fatigue measure at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Visual Analog Scale score at 8 weeks [ Time Frame: 8 weeks ]
  • Cognitive fatigue measure at 8 weeks [ Time Frame: 8 weeks ]
  • Motor fatigue measure at 8 weeks [ Time Frame: 8 weeks ]
Not Provided
Not Provided
 
Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

The purpose of this study is to determine whether aspirin is effective for treatment of fatigue caused by multiple sclerosis (MS).

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 person?s 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
Drug: Aspirin
. Participants will be randomized in a 1:1:1 ratio to receive aspirin 1300 mg/d, aspirin 162 mg/d, or placebo for 8 weeks.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
62
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Confirmed relapsing-remitting or secondary progressive multiple sclerosis,
  • Ambulatory for distance of at least 100 m without gait assistance,
  • Persistent fatigue for at least 8 weeks that is not attributable to causes other than MS, and
  • Will be able to complete questionnaires and cognitive testing.

Exclusion criteria:

  • Other evident causes for fatigue,
  • Recent MS disease activity or specific changes in MS therapy,
  • Current use of ASA or other NSAIDs,
  • Use of CNS stimulants,
  • Use of medications that contraindicate the use of ASA, ASA allergy or sensitivity,
  • History of peptic ulcer disease or GI bleed,
  • Alcohol abuse,
  • Pregnancy, and
  • Laboratory abnormalities.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00467584
06-004850
No
Dean Wingerchuk, Mayo Clinic
Mayo Clinic
National Multiple Sclerosis Society
Principal Investigator: Dean M. Wingerchuk, M.D., MSc Mayo Clinic
Mayo Clinic
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP