"Completeness of Response" Following Treatment With Treximet™ for Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Many clinical trials may not fully explore criteria that are important to some migraine
      patients' definition of "complete response." This study offers the opportunity to evaluate
      the effectiveness of Treximet™ when non-standard criteria are examined (for example, neck
      pain, irritability or fatigue). Subjects enrolled at 8 investigative sites will complete 2
      visits. Subjects will complete a Completeness of Response Survey at Visit 1 considering their
      usual migraine medication (a triptan) and a Completeness of Response Survey at Visit 2
      considering their study medication (Treximet™).
    

Detailed description: 
      At the screening visit (Visit 1), following written informed consent, subjects will provide a
      medical, medication and migraine history. A physical and neurological exam and pregnancy test
      (if appropriate) will be performed. Vital signs will be recorded for all subjects. The
      Headache Impact Test (HIT-6) and Baseline Patient Perception of Migraine Questionnaire
      (PPMQ-R) will be completed with the Baseline Completeness of Response Survey (CORS)
      considering migraine therapy (triptan) utilized during the 3 months prior to enrollment. The
      Completeness of Response Survey will collect traditional and non-traditional symptoms.
      Subjects are instructed to treat all migraines that occur in the next 2 months. Subjects will
      treat with a single tablet of Treximet™ as soon as they have a headache indicative of
      migraine and are encouraged to treat when the headache is mild. A Headache Diary documenting
      onset of headache pain and associated symptoms, time of treatment with study medication,
      symptoms at 2 hours following treatment, time of relief, recurrence of symptoms within 24
      hours post-treatment, and adverse events will be dispensed with study medication. Subjects
      may take a 2nd dose of study medication or medication determined by the investigator for
      rescue of persistent or recurring headache at 2 or more hours following the 1st dose of study
      medication. Alternate rescue medication can be provided at the discretion of the investigator
      but may not include triptan, non-steroidal anti-inflammatory (short-acting NSAID between 6
      hours before and 2 hours after study medication or long-acting NSAID between 24 hours before
      and 24 hours after study medication), or ergotamine-containing or ergot-type medication.
      Subjects must be headache-free for 24 hours before recording the onset of a "new" migraine
      attack. The study coordinator will contact subjects at Month 1 to verify treatment and diary
      compliance.

      At Visit 2, following 2 months of treatment with Treximet™, the subject will return to the
      study site and return completed Headache Diaries. The End of Study CORS, CORS Comparator and
      End of Study PPMQ-R will be completed considering response with study medication. Adverse
      events will be documented and Diaries and Questionnaires will be reviewed.
    

Intervention name(s): sumatriptan succinate 85 mg/naproxen sodium 500 mg (Treximet)
Intervention type(s): Drug
Intervention description(s): Treximet 1 tablet as soon as the patient has headache indicative of migraine. May be repeated between 2 and 24 hours post-treatment for persistent or recurring headache. Subjects should not take more than 2 Treximet tablets in 24 hours.
Intervention MeSH terms: Naproxen; Sumatriptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Headache, Migraine