Two center, randomized pilot study of migraine prophylaxis comparing paradigms using pre-emptive frovatriptan or daily topiramate: research and clinical implications.

OBJECTIVE: To compare the efficacy and clinical benefit of 2 paradigms of migraine prevention using pre-emptive frovatriptan and daily topiramate. The study compares the paradigms of pre-emptive use of frovatriptan, a drug approved for acute migraine, and the daily use of topiramate, a Federal Drug Administration-approved and -accepted standard for migraine prophylaxis. BACKGROUND: Traditionally, preventive treatment of migraine required daily medication. However, recent studies suggest that pre-emptive prophylaxis may be beneficial to those migraineurs who can predict an attack of migraine based on premonitory symptoms and treat during that phase. METHODS: A total of 76 adult subjects with a diagnosis of migraine were screened for the study. During a 1-month baseline period, subjects demonstrated through a daily diary that they predicted at least 50% of migraine attacks during the premonitory phase and treated with their usual medication. Of these, 55 were randomized to either Group A (daily topiramate) or Group B (frovatriptan during premonitory symptoms); 44 completed the study. The treatment period lasted 2 months. The subjects answered the Migraine-Specific Quality of Life Questionnaire at randomization, and at Weeks 4 and 8. The revised Patient Perception of Migraine Questionnaire was answered 24 hours after taking frovatriptan (Group A, for break-through headaches; Group B, treatment during premonitory symptoms). RESULTS: The number of migraine attacks and headache days per month decreased significantly from baseline for both Groups A and B. Subjects in Group A had considerably more adverse events leading to study withdrawal than in Group B (18% vs 4%). Though this study was not powered to directly compare the efficacy of the 2 drugs, topiramate showed superiority over frovatriptan at Month 2 in reduction of headache days, which was a secondary end point in the study (P = .036). CONCLUSIONS: This pilot study demonstrated that statistical benefit for reduction of headache days over baseline for both pre-emptive frovatriptan and daily topiramate. Subjects utilizing pre-emptive frovatriptan experienced fewer adverse events leading to study withdrawal. Subjects utilizing daily topiramate had fewer headache days at Month 2.

Multi-center comparison of response to a single tablet of sumatriptan 85 mg and naproxen 500 mg vs usual therapy treating multiple migraine attacks as measured by the completeness of response survey.

OBJECTIVE: To investigate a broad definition of migraine resolution that extends beyond specific migraine-associated diagnostic symptoms as measured by the Completeness of Response Survey. METHODS: Conducted at 8 sites, 135 subjects treated migraines with SumaRT/Nap over 2 months. To measure subjects' experiences with SumaRT/Nap compared to their usual migraine medication, the Headache Impact Test, Revised Patient Perception of Migraine Questionnaire, and Completeness of Response Survey were administered at baseline and at 2 months. RESULTS: The effects of the study medicine compared to the subjects' usual migraine medicine reached statistical significance in decreasing headache severity, lessening of associated symptoms, and attaining complete relief with a single dose (60.04% of attacks resolved at 2 hours post-treatment). CONCLUSION: Compared to a subject's usual treatment, SumaRT/Nap used early and consistently for treatment of acute migraine offers important clinical improvements, including lessening of associated symptoms beyond International Headache Society criteria. CLINICAL TRIAL REGISTRATION NUMBER: NCT00893737.

Nurse-based education: an office-based comparative model for education of migraine patients.

BACKGROUND: A person with migraine needs to be prepared to make therapeutic decisions on her own. For this reason, patients often need education to understand the nuisances of managing theirmigraines. In this study an educationalCD-ROM/DVD that described the pathophysiology was utilized by nurses in an office-based primary care setting for patient education. Outcomes from this encounter were measured. OBJECTIVES: (1) Identify educational information that assisted migraine patients feel empowered to more effectively manage migraine; (2) encourage patients to intervene during the mild headache phase of the migraine; (3) measure education related changes in patient satisfaction and confidence regarding management of migraine; (4) measure changes in nurse satisfaction and confidence in educating migraine patients; (5) compare the effectiveness of 3 methods of delivery of nurse-based migraine education. METHODS: One hundred and eighty migraineurs at 21 primary care practices were divided into 4 groups: group A watched the CD-ROM/DVD in the office with a nurse available to answer questions; group B was given the CD-ROM/DVD by a nurse knowledgeable of the content; group C received the educational CD-ROM/DVD from a nurse without comment; group D received no educational material. The 10 nurses in groups A and B participated in a 45-minute teleconference that reviewed the information on the CD-ROM/DVD. Patients and nurses answered a pre- and post-study migraine questionnaire. Patients filled in a treatment diary online within 24 hours of treating a migraine. Nurses completed a satisfaction questionnaire. RESULTS: Of the 17 educational points tested on the pre-test, 75% of patients and nurses already knew about 1/3 of the information. There was significant improvement noted for both patients and nurses on the post-test in groups A, B, and C but not in group D. The percentage of correct responses by patients and nurses was directly and statistically significantly correlated with the involvement of the nurse in the educational effort. As a result of the education, patients felt more confident in their ability to manage and treat migraine. Likewise, nurses gained increased confidence in teaching patients about migraine. Patients did not intervene with acute therapy during the mild headache phase. Overall, 94% of the nurses were very satisfied or satisfied with the format and information provided. CONCLUSIONS: All but objective 2 were met for groups A, B, and C compared to control group D. Patients readily accepted nurse-directed education and assimilated information that increased their confidence to manage migraine. This emphasizes the importance of training nurses about materials used to educate patients.