Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
Condition: Multiple Sclerosis; Fatigue
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Intervention: High Dose Aspirin (1300 mg/day); Low Dose Aspirin (162 mg/day); Placebo
Intervention description: 1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks; 162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks; Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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