A combination of SumaRT/Nap (group A) did not appear to reduce migraine headache frequency over a 3-month period. Subjects using naproxen sodium (group B) alone and completing the study per protocol had a marked statistically significant reduction in migraine headache days. Both groups completing the study per protocol had experienced clinically meaningful 2-hour headache relief. This suggests there may be a subset of patients with chronic migraine that are responsive to
high doses of naproxen as an acute intervention with a significant prophylactic benefit. Subjects randomized to SumaRT/Nap experience benefit, primarily as an acute intervention. This hypothesis may warrant future larger Selleck CT99021 scale clinical trials. Frequent dosing of SumaRT/Nap or naproxen sodium was well tolerated in this study. Chronic migraine (CM) is a relatively new construct in the taxonomy of primary headache disorders. Criteria for CM were first created in the 2004 International Classification of Headache Disorders, 2nd edition (ICHD-II classification), but revised in an appendix definition in 2006.
In June of 2013, ICHD III was released for comments. It includes important revisions of CM and medication overuse headache Tanespimycin ic50 (MOH) and specifically permits dual diagnosis of CM and MOH. This means that in patients with a history of episodic migraine experiencing 15 or greater days of headache per month and treating with quantities of medication in excess of defined limits of medication overuse will be diagnosed with 1.3 chronic migraine and 8.2 medication overuse headache until the offending drug has been reduced or eliminated. While this is an important advancement, it also suggests that that these diagnoses continue to be both allusive and Metformin inconclusive. Migraineurs with CM or chronic daily headache (CDH) were excluded from regulatory trials of acute migraine medications. Consequently, there
is a paucity of scientific evidence on efficacy or safety of acute migraine medications in this patient population. Complicating the taxonomy and acute treatment of CM is its relationship to medication overuse (MO) and medication overuse headache (MOH). There are legitimate concerns within the headache community that the too frequent use of many if not most acute treatment medications can transform episodic migraine into persistent and intractable CM. This iatrogenic cause of CDH in turn, increases disability and poses potential safety concerns for this patient population. Further, MOH is a secondary headache disorder and technically CM cannot be diagnosed until MOH (and any other secondary headache disorder) has been ruled out or appropriately managed.