Complicating matters even further is the recent acknowledgment that several triptans that are historically considered acute interventions, have Class A and/or B evidence for efficacy when used as a (short-term) prophylactic medication. Thus, consider the confusion of the following scenario: a patient with CM is utilizing a daily triptan at the earliest onset of a headache and rarely experiences a headache lasting more than 1 hour. In the diary record, the frequency of migraine headache days (>4 hours a day of headache) decreases from 25 to 6
days a month over the previous 3 months. Is the triptan being used as an abortive or preventive treatment? The patient is using a triptan on greater than 10 days a month, but her headache pattern is improved. Is she diagnosed with MO? Does she now have episodic migraine (EM)? Is she in MOH despite Tanespimycin her headache pattern improving? An ideal acute treatment in CM would provide both sustained 2-hour headache relief and protect the nervous system from future migraine attacks. Acute medications with these attributes could potentially reduce the risk of MOH and likely provide synergistic benefit with other pharmacological
and non-pharmacological prophylactic interventions. This pilot study attempts to generate hypotheses for future study of acute treatment in CM by comparing the use of a combination of sumatriptan (85 mg) plus naproxen sodium (500 mg) vs naproxen sodium (500 mg) used in a unique treatment paradigm. During the first month of this study, these medications were utilized both as a daily preventative SB203580 in vivo and if needed, a second dose could be utilized
as acute treatment. During the subsequent 2 months, the study medication was used as acute treatment for up to 14 days per month. The primary endpoint of this study was a change in migraine headache days from baseline to month 3 of the study. This study was conducted in accordance with the Declaration of Helsinki, all relevant US federal regulations, and in compliance with the International Conference on Harmonization guideline for Good Clinical Practice. The study protocol, informed consent forms, and all other appropriate Carbohydrate study-related documents were approved by the Sterling Institutional Review Board/Ethics Committee. Written informed consent was obtained from each patient prior to any protocol-related activities. The study was registered at ClinicalTrials.gov (NCT01090050) and sponsored by a grant from GlaxoSmithKline, Research Triangle Park, NC. This is a two-center, double-blind, randomized, parallel-group, comparator pilot trial of 28 subjects, 18 to 65 years of age, with the ICHD-II appendix definition of CM. As this was a pilot study aimed at exploring proposed hypotheses with no intention of establishing efficacy, a formal power analyses was not completed. The sample size was determined considering the study design.