Conflict of Interest Statement: Dr. Edwards has received research grants from Allergan and GlaxoSmithKline. Dr. Rosenthal has no conflict of interest to report. Dr. Farmer has no conflict of interest to report. Dr. Cady has served as a consultant for GlaxoSmithKline, Merck, and Ortho-McNeil. Research grants from Allergan, Endo Pharmaceuticals, GlaxoSmithKline, PuraMed BioScience, Wyeth, and Zogenix. Ms. Browning has no conflict of interest to report.
Evaluation of Sumatriptan-Naproxen in the Treatment of Acute Migraine: A Placebo-Controlled, Double-Blind, Cross-Over Study Assessing Cognitive Function
Article first published online: 13 FEB 2013
© 2012 American Headache Society
Headache: The Journal of Head and Face Pain
Volume 53, Issue 4, pages 656–664, April 2013
How to Cite
Edwards, K. R., Rosenthal, B. L., Farmer, K. U., Cady, R. K. and Browning, R. (2013), Evaluation of Sumatriptan-Naproxen in the Treatment of Acute Migraine: A Placebo-Controlled, Double-Blind, Cross-Over Study Assessing Cognitive Function. Headache: The Journal of Head and Face Pain, 53: 656–664. doi: 10.1111/head.12052
Financial Support: This investigator-initiated research was funded by GlaxoSmithKline.
Clinical Trial Number: NCT00837044 on http://www.clinicaltrials.gov
- Issue published online: 4 APR 2013
- Article first published online: 13 FEB 2013
- Accepted manuscript online: 26 DEC 2012 07:11AM EST
- Manuscript Accepted: 3 DEC 2012
- Endo Pharmaceuticals
- PuraMed BioScience
- cognitive efficiency;
- mental efficacy workload test;
- acute migraine;
To assess the cognitive effects of acute migraine and the subsequent impact of acute treatment in a controlled setting.
Cognitive dysfunction may be an associated symptom in patients with migraine with or without aura. The loss of cognitive efficiency in migraine may be disabling and is often under recognized.
Thirty migraine patients were prospectively studied for cognitive function before and then at the beginning of a migraine using a computerized cognitive battery (Mental Efficacy Workload Test). Each patient then was treated for 2 headaches in a cross-over manner with sumatriptan-naproxen (Treximet®) or placebo in a double-blind, placebo-controlled fashion with cognitive testing repeated at 1 and 2 hours post-dose.
Twenty-five of the 30 screened migraine subjects completed study-specific procedures and were included in the data analyses. There were no significant side effects from Treximet or placebo and no serious adverse events. At the onset of headache, there was a statistically significant decline in overall cognitive efficiency compared with the baseline cognitive testing (migraine-free) for all subjects (P = .001 paired samples t-test). For subjects taking Treximet compared with taking placebo, there was a statistically significant return to cognitive efficiency by measures of immediate and sustained attention, visual-spatial awareness, mental flexibility, and reaction time between 1 hour and 2 hours (P = .05). There was no statistical significance between patients taking Treximet or placebo in measures of complex reasoning or fine motor coordination. Subanalysis showed a correlation between headache severity and Performance Index in the Treximet group but not in the placebo group (∼Fig. 6).
There is a significant decline in global cognitive efficiency at the onset of an attack of migraine. The use of Treximet allows a significantly faster recovery time in some measures of cognitive efficiency compared with placebo. Decline of cognitive efficiency may be independent of headache severity.