A Study to Evaluate Aspirin for Treating Multiple Sclerosis-related Fatigue


About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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

Exclusion Criteria:

  • Other evident causes for fatigue:
    • Untreated depression or screening Center for Epidemiologic Studies Depression (CES-D) scale greater than 28;
    • Significant cognitive impairment (Baseline Short Test of Mental Status score of less than 29/38);
    • Narcolepsy, uncontrolled sleep apnea, or other primary sleep disorder judged to be likely a major contributor to fatigue;
    • Screening Epsworth Sleepiness Scale score greater than 15;
    • Uncontrolled hypothyroidism or anemia;
    • Other medical illness judged by the investigator to affect the participant''s fatigue complaints including current viral, bacterial, mycobacterial, or fungal infection.
  • MS Disease Activity and Treatment:
    • Clinical exacerbations within 2 weeks prior to screening visit;
    • Corticosteroid use within 4 weeks prior to screening visit;
    • Beta-interferon, glatiramer acetate, immunosuppressant drugs (mitoxantrone, azathioprine, etc.) are permitted if a stable dose has been used for greater than or equal to 4 weeks and there is no temporal association of drug administration with perceived fatigue; elective on-study dose/regimen changes are not permitted.
  • Current or Recent Fatigue Therapy and Other Medications:
    • Use of more than two doses of ASA (aspirin) greater than 81 mg/d within 2 weeks of screening visit;
    • Use of MS fatigue medications within 2 weeks of screening visit (including amantadine or Central Nervous System stimulants such as modafinil, methylphenidate, and pemoline);
    • Symptomatic medications (antidepressants, anti-spasticity agents, non-narcotic analgesics) are permitted if a stable dose has been used for > 4 weeks prior to screening for antidepressants and > 2 weeks prior to screening for other symptomatic therapies and there is no temporal association of drug administration with perceived fatigue; elective on-study dose changes are not permitted;
    • Current use of acetazolamide, antiplatelet agents or anticoagulants, COX-2 inhibitors, methotrexate, oral hypoglycemic medications.
  • Medical Contraindications to ASA use:
    • Allergy to ASA or Non-Steroidal Anti-Inflammatory drugs;
    • Syndrome of asthma, rhinitis and nasal polyps;
    • History of confirmed peptic ulcer or gastrointestinal or severe gynecological bleeding.
  • General Health Concerns:
    • Significant uncontrolled disease of cardiovascular, pulmonary, hepatic, renal, endocrine, rheumatological, neurological, gynecological, or gastrointestinal systems;
    • Pregnancy or unwillingness to utilize contraception;
    • History of alcohol or drug abuse within 6 months of screening or current alcohol intake > 3 drinks/day.
  • Laboratory Exclusions (available values obtained within 8 weeks prior to screening visit are acceptable for all except the pregnancy test):
    • Positive pregnancy test;
    • Hemoglobin less than 11.0 g/dL (women) or 13.0 g/dL (men);
    • Platelet count < 120,000/μL;
    • Serum creatinine level > 1.4 mg/dL (women) or 1.6 mg/dL (men) ;
    • Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) level greater than 2.5 times the upper limit of normal.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Dean Wingerchuk, M.D.

Closed for enrollment

Contact information:

Dean Wingerchuk M.D.


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