IRB Number:

06-004850

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is being done to:
-find out what effects (good and bad) that aspirin has on you and your fatigue related to multiple sclerosis
-find out what effects that aspirin has on measures of cognitive fatigue (thinking) and motor fatigue (strength) and how aspirin might reduce fatigue

Who is Eligible to Participate in the Study?

Male and Female. Age 18 to 65.

Minimum Age:

18

Maximum Age:

65

What is Involved With this Study?

Screening visit: This is the first study visit. You will complete nine brief questionnaires that evaluate your MS-related fatigue, sleep, pain, and overall function. This will take 40-60 minutes. You will also have a review of your fatigue symptoms, brief neurological examination and complete a test of mental concentration called the PASAT. Finally, if you meet study eligibility criteria to this point, you will have blood drawn (about 2 teaspoons) to test for causes of fatigue. If you do not meet all of the entry criteria for the study at this point, then you may be eligible for rescreening at a later date (another attempt to enter the study) at the discretion of the medical doctor.

Baseline visit: About 1-2 weeks after the screening visit, you will return to the clinic to repeat the questionnaires, PASAT, and have blood drawn (about 2 teaspoons). If you are
a woman who can become pregnant, you will have a urine pregnancy test. You will also do arm and leg strength testing in the motor laboratory for about 45 minutes. After this visit, you will be put in one of three groups by chance (like the flip of a coin). One group will receive 1300 milligrams of aspirin daily (equivalent to 4 regular aspirin). The second group will receive 162 milligrams of aspirin daily (equivalent to 2 "baby" aspirin). The third group will receive a placebo ("sugar pill") that does not contain aspirin. The Mayo Clinic Pharmacy in Minnesota will directly mail you the study medication based on the group you are in. You will take the medication every day (2 pills in the morning and 2 pills at noon) for the next 8 weeks. You, your doctor, and the staff that work with you during the study will not know which group you are in during
the study.

Week 4 visit: You will return to the clinic to complete the questionnaires, PASAT, motor lab testing, and have your blood drawn (about 1 tablespoon). You will be asked
questions about whether the study medication is helping you and if you notice any side effects.

Week 8 visit: This is the last study visit. You will return to the clinic to complete the questionnaires, PASAT, motor lab testing, and have your blood drawn (about 1
tablespoon). You will be asked questions about whether the study medication is helping you, if you noticed any side effects, and to guess which study group you were in.
During the study, you must not take aspirin, anti-inflammatory medications such as ibuprofen and similar drugs, or blood thinners. You should contact the study physician before beginning any new prescription medications.

How long will the Study run?

9-10 weeks

Who can I Contact for Additional Information on this Trial?

Pamela Long (Florida)
(904) 953-7719

Darcy Rauchwarter (Minnesota)
(507) 284-9360

Teri Radam (Arizona)
(480) 301-8756

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 09/26/2009