Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
This is an open label, 6 month cross over study in 50 migraine patients fulfilling
International Headache Society Classification criteria for migraine headache with and without
aura having 2-6 migraines per month and not over 14 days a month of headaches in the previous
3 months. Baseline Headache Impact Test -6 (HIT-6) will be obtained and 25 patients will
administer Treximet as needed for 3 months and then 2 Aleve and 100mg Imitrex taken
concomitantly as needed for 3 months. The other 25 patients will administer 2 Aleve and 100mg
Imitrex taken concomitantly as needed for 3 months and then Treximet as needed for 3 months.
In addition to Revised Patient Perception of Migraine Questionnaire (PPMQ-R)data, a detailed
diary will be recorded regarding number of tablets taken per attack, compliance, rescue
treatment, when patients treated their migraine attack (mild, moderate, or severe), onset of
pain reduction (pain relief and pain free, and 24 hour pain relief and sustained pain free
response.