The distribution and migration of North American birds
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Abstract
OBJECTIVE: A post-hoc analysis was performed to determine whether pain relief rates were consistent across a sequence of migraines treated with MAP0004 in a Phase 3 trial. BACKGROUND: Oral administration of medication is common for the acute treatment of migraine. Gastric stasis is associated with migraine, and can significantly alter the rate of intestinal absorption of an oral medication, leading to inconsistent response. MAP0004, an investigational dihydroergotamine (DHE) product candidate, delivers DHE systemically via the lungs, bypassing the gastrointestinal tract. DHE Tmax measurements between 9-17 min were consistently recorded in a MAP0004 clinical trial. However, consistent Tmax values do not necessarily correlate with a consistent clinical response. DESIGN/METHODS: This post-hoc analysis included subjects enrolled in the MAP0004 cohort of an open-label safety study who experienced at least 25 qualifying migraines (QMs). To assess consistency of MAP0004 efficacy; pain relief, pain free, sustained pain relief, and sustained pain free endpoints were compared between the 1st, 5th, 15th, and 25th QM. RESULTS: A total of 153 subjects were analyzed. Pain relief at 2 hr for the 1st QM was reported by 51.0% of subjects. Compared to the 1st QM, there was no statistically significant difference in the percentage of subjects reporting pain relief at 2 hr for each subsequent migraine. There was no statistically significant difference when comparing across the four migraines evaluated. Similarly, analysis of pain free at 2 hr (1st QM=20.9%), sustained pain relief 2-24 hr (1st QM=36.6%), and sustained pain free 2-24 hr (1st QM=15.0%) were not statistically different from the 1st QM or comparing across the 1st, 5th, 15th and 25th QMs. CONCLUSIONS: In this post-hoc analysis, MAP0004 provided consistent migraine pain relief for the 1st, 5th, 15th or the 25th QM assessed over approximately one year. Supported by: MAP Pharmaceuticals, Inc. Disclosure: 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. Dr. Connors has received personal compensation for activities with MAP Pharmaceuticals. Dr. Li has received personal compensation for activities with Merck & Co., Inc., as an employee. Dr. Kellerman has received compensation for serving on the Board of Directors of Ockham CRO.
| Reference Key |
openalex_W2334256835
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|---|---|
| Authors | Spencer Fullerton Baird |
| Journal | american journal of science |
| Year | 1866 |
| DOI |
10.2475/ajs.s2-41.121.78
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| URL | |
| Keywords | Keywords not found |
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