Status:
TERMINATED
Aspirin for Treatment of Multiple Sclerosis-Related Fatigue
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Multiple Sclerosis Society
Conditions:
Multiple Sclerosis
Fatigue
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether aspirin is effective for treatment of fatigue caused by multiple sclerosis (MS).
Detailed Description
Fatigue is the most common symptom of multiple sclerosis (MS), affecting up to 90% of people with the disease. MS-related fatigue can be disabling even when other features of MS are mild. It can inter...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00467584
Start Date
July 1 2007
End Date
September 1 2013
Last Update
May 20 2014
Active Locations (1)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259