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- W2805425170 abstract "OBJECTIVE: This post-hoc analysis compares rescue medication use after treatment with MAP0004 vs. placebo. BACKGROUND: Relief of pain can be measured by several endpoints, including sustained pain relief, recurrence and the extent of rescue medication use. Migraine patients use rescue medication when symptoms persist or recur after initial treatment. Rescue medication use is a good indication of the extent of relief provided by initial treatment. MAP0004 is an investigational product candidate that consists of dihydroergotamine (DHE) delivered via a TEMPO ® breath-actuated inhaler. MAP0004 was effective in the acute treatment of migraine in a Phase 3 trial. DESIGN/METHODS: Subjects were instructed to refrain from taking rescue medications for at least 2 hr after study treatment administration. Subjects who did not respond to study treatment and subjects who had initial relief followed by pain recurrence were allowed to take rescue medication 2 hrs after study treatment administration. An electronic diary was used to collect rescue medication use information. RESULTS: This post-hoc analysis included 794 patients randomized (1:1) to receive double-blind treatment with MAP0004 or placebo. Rescue medication use in the double-blind period was consistently lower with MAP0004 than with placebo at 2 hr (4% vs 8%, P =0.0261), 4 hr (19% vs 37%, P P P CONCLUSIONS: In this post-hoc analysis of the double-blind period of a Phase 3 trial, rescue medication use was significantly lower with MAP0004 recipients as compared to placebo. Supported by: MAP Pharmaceuticals, Inc. Disclosure: Dr. Kellerman has received compensation for serving on the Board of Directors of Ockham CRO. Dr. Kori has received personal compensation for activities with MAP Pharmaceuticals, Inc. Dr. Kori holds stock and/or stock options in MAP Pharmaceuticals, Inc. Dr. Kori has received research support from MAP Pharmaceuticals, Inc. Dr. Lu is an employee of MAP Pharmaceuticals." @default.
- W2805425170 created "2018-06-13" @default.
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- W2805425170 date "2013-02-12" @default.
- W2805425170 modified "2023-09-23" @default.
- W2805425170 title "Rescue Medication Use during MAP0004 Phase 3 Trial (P01.087)" @default.
- W2805425170 hasPublicationYear "2013" @default.
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