Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

This is an interventional treatment trial for Multiple Sclerosis Read More

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:

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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