Migraine Clinical Trial
Official title:
TreximetTM in the Prevention and Modification of Disease Progression in Migraine
This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine.
Two investigative centers will enroll 40 subjects in the United States. Subject
participation in the 5 visit study will last 4 months.
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. An
electrocardiogram (ECG) will be completed. A Lifestyle Choices for Better Migraine
Management Questionnaire (Lifestyle Questionnaire) will be completed. Eligible subjects then
complete a 1-month Baseline Period and treat migraine with their current preferred treatment
of choice, documenting headache severity and associated symptoms in a 30-day Baseline Diary.
At Visit 2, the Baseline Diary will be reviewed and a pregnancy test will be collected from
all subjects of childbearing potential. Vital signs will be collected and Adverse Events
documented. Subjects continuing to meet eligibility criteria will be randomized 1:1 to
Treximet or naproxen and 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. Subjects will view an educational digital
video disc (DVD) concerning lifestyle modification, receive a copy for home viewing,
complete the Lifestyle Questionnaire, and receive 3 copies of the Lifestyle Questionnaire
for weekly completion between Visits 2 and 3. The Migraine Disability Assessment
questionnaire (MIDAS) will be completed and a 30-day Treatment Period Diary will be
dispensed.
At Visits 3 and 4, Adverse Events will be collected, completed Diaries will be reviewed, and
Drug Accountability performed. Pregnancy tests will be collected from all subjects of
childbearing potential. Vital signs will be collected. Completed Lifestyle Questionnaires
will be collected, a Lifestyle Questionnaire will be completed in the office, and 3 copies
will be dispensed for weekly completion between visits. Study medication for the following
month will be dispensed with a 30-day Diary.
At Visit 5, Adverse Events will be collected, completed Diaries will be reviewed, and Drug
Accountability performed. Pregnancy tests will be collected from all subjects of
childbearing potential. Vital signs will be collected. Completed Lifestyle Questionnaires
will be collected and a Lifestyle Questionnaire will be completed in the office. Subjects
will complete the MIDAS before exiting the study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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