Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

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, and
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