Treximet in the Treatment of Chronic Migraine

One investigative center will enroll 40 subjects in the US.

At Visit 1, following informed consent, a medical, migraine, and medication history will be
collected and a physical and neurological exam with vital signs will be performed. A
12-lead ECG will be completed. Eligible subjects will complete a 1-month Baseline Period
and treat migraine with their current preferred treatment of choice. Throughout the study,
subjects will complete daily Headache Diaries reporting headache severity and associated
symptoms with use of study medication in each 30-day period.

At Visit 2, subjects continuing to meet eligibility criteria will be randomized 1:1 to
Treximet or naproxen and provided with medication to treat daily for 30 days. At Visits 3
and 4 subjects will be provided with study medication to treat on 14 or fewer days per
month. Subjects will be encouraged to treat their migraine attacks within 1 hour of onset of
headache pain and while the pain is still mild. Adverse events will be collected beginning
from the first dose of study medication. Subjects exit the study at Visit 5 after a 3-month
Treatment Period.

The study provides opportunity to evaluate the usefulness of patient education with a
15-minute DVD concerning the processes of headache evolution and lifestyle changes for
better headache management. At Visit 2, subjects will view the DVD in-clinic with a copy
provided for at-home viewing. Subjects will complete a Lifestyle Choices for Better
Migraine Management Questionnaire at each visit and receive 3 copies to be completed weekly
and returned at the following visit.

The Migraine Disability Assessment questionnaire (MIDAS) will be completed at Visits 2 and 5
to determine the level of pain and disability caused by headache.