Migraine Treatment Satisfaction With Treximet Versus Concomitant 2 Aleve and Imitrex

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.

Timeline

Start

2009-12

Primary completion

2011-05

Completion

2011-05

Publications

• Results Revicki DA, Kimel M, Beusterien K, Kwong JW, Varner JA, Ames MH, Mahajan S, Cady RK. Validation of the revised Patient Perception of Migraine Questionnaire: measuring satisfaction with acute migraine treatment. Headache. 2006 Feb;46(2):240-52. doi: 10.1111/j.1526-4610.2006.00289.x.
• Results Landy S, DeRossett SE, Rapoport A, Rothrock J, Ames MH, McDonald SA, Burch SP. Two double-blind, multicenter, randomized, placebo-controlled, single-dose studies of sumatriptan/naproxen sodium in the acute treatment of migraine: function, productivity, and satisfaction outcomes. MedGenMed. 2007 Jun 7;9(2):53.
• Results Smith T, Blumenthal H, Diamond M, Mauskop A, Ames M, McDonald S, Lener S, Burch S. Sumatriptan/Naproxen sodium for migraine: efficacy, health related quality of life, and satisfaction outcomes. Headache. 2007 May;47(5):683-92. doi: 10.1111/j.1526-4610.2007.00790.x.
• Results 4. Cady RK, et al. Consistent medication satisfaction with sumatriptan RT Technology and naproxen sodium for acute migraine treatment. Poster presented at 13th Congress of the International Headache Society (IHS), June 28-July 1, 2007; Stockholm, Sweden.
• Results Mathew NT, Landy S, Stark S, Tietjen GE, Derosier FJ, White J, Lener SE, Bukenya D. Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. Headache. 2009 Jul;49(7):971-82. doi: 10.1111/j.1526-4610.2009.01458.x. Epub 2009 May 27.
• Results Kimel M, Hsieh R, McCormack J, Burch SP, Revicki DA. Validation of the revised Patient Perception of Migraine Questionnaire (PPMQ-R): measuring satisfaction with acute migraine treatment in clinical trials. Cephalalgia. 2008 May;28(5):510-23. doi: 10.1111/j.1468-2982.2007.01524.x. Epub 2008 Mar 31.

Drugs

Indications