Treximet in Acute Migraine Headache: Assessing Cognitive Function

Summary

Migraine headache occurs frequently in women more than men and is associated with symptoms not only of significant pain but also of symptoms typically including of photophobia, phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from lack of concentration, difficulty in word finding or inability to remember. Many of these cognitive symptoms seem to be independent of the pain intensity and may occur completely separately from the headache pain but can be disabling. It is likely that the frequency and importance of cognitive symptoms associated with migraine are underreported. The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an efficient and accurate measure of cognition during migraine headache. Treximet is a new migraine treatment recently FDA approved for the treatment for the relief of acute migraine that may be effective for the cognitive symptoms for migraine patients who have a history of cognitive dysfunction during a migraine headache. The primary efficacy parameter is to evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache measuring neuropsychological function using the MEWT during the migraine and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A double blind, placebo-controlled, crossover study was chosen so that each patient may be her or his own control. It is the intent of this study to determine the type and intensity of cognitive dysfunction associated with migraine headache and to what extent that Treximet may relieve the cognitive dysfunction in a safe and effective manner.

Timeline

Start

2009-02

Primary completion

2009-07

Completion

2009-09

Publications

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• Background Farmer K, Cady R, Reeves D, Bleiberg J. Cognitive efficiency following migraine therapy. In: J. Olsen, T.J. Steiner, R.B. Lipton (Eds.) Reducing the burden of headache: Frontiers in headache research (pp 46-51) New York: Oxford University Press 2003
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• Background Wilken JA, Sullivan CL, Lewandowski A, Kane RL. The use of ANAM to assess the side-effect profiles and efficacy of medication. Arch Clin Neuropsychol. 2007 Feb;22 Suppl 1:S127-33. doi: 10.1016/j.acn.2006.10.007. Epub 2006 Nov 20.
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• Background Roebuck-Spencer T, Sun W, Cernich AN, Farmer K, Bleiberg J. Assessing change with the Automated Neuropsychological Assessment Metrics (ANAM): issues and challenges. Arch Clin Neuropsychol. 2007 Feb;22 Suppl 1:S79-87. doi: 10.1016/j.acn.2006.10.011. Epub 2006 Nov 21.
• Edwards KR, Rosenthal BL, Farmer KU, Cady RK, Browning R. Evaluation of sumatriptan-naproxen in the treatment of acute migraine: a placebo-controlled, double-blind, cross-over study assessing cognitive function. Headache. 2013 Apr;53(4):656-64. doi: 10.1111/head.12052. Epub 2013 Feb 13.

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