Aspirin for Treatment of Multiple Sclerosis-Related Fatigue

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis, Fatigue

In brief

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

Key facts

Study ID

NCT00467584

Run by

Mayo Clinic

People needed

62

Starts

2007-07-01

Expected to finish

2013-09-01

Last updated by the study team

2014-05-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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