Treximet in the Treatment of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to evaluate the hypothesis that use of Treximet in patients
      with chronic migraine, when used on a short term daily basis and as rescue for break through
      attacks, will reduce migraine frequency and impact.
    

Detailed description: 
      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 digital versatile disc (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.
    

Intervention name(s): Sumatriptan/Naproxen Sodium; Naproxen Sodium
Intervention type(s): Drug; Drug
Intervention description(s): Each tablet of Sumatriptan/Naproxen Sodium for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.; Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.
Other intervention name(s): Treximet
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Migraine; Migraine; Treximet; naproxen; sumatriptan