Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Multiple Sclerosis Society
• Treatments: Aspirin

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