Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine
Condition: Migraine
MeSH terms: Migraine Disorders; Disease Progression
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Sumatriptan/Naproxen Sodium; Naproxen Sodium
Intervention type(s): Drug; Drug
Intervention description(s): Each tablet of Treximet for oral administration contains Sumatriptan 85mg / Naproxen Sodium 500mg. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.; Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.
Other intervention name(s): Treximet; Naproxen
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Frequent migraine; Migraine transformation; Migraine; Treximet; Naproxen; Sumatriptan