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
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Drug: Aspirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Modified Fatigue Impact Scale score at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: March 2007
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467584

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
National Multiple Sclerosis Society
Investigators
Principal Investigator: Dean M. Wingerchuk, M.D., MSc Mayo Clinic
  More Information

No publications provided

Responsible Party: Dean Wingerchuk, Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00467584     History of Changes
Other Study ID Numbers: 06-004850
Study First Received: April 26, 2007
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014