Skip to main content

Analysis of subjects with menstrually related migraine vs. Non-menstrually related migraine treated with MAP0004

Menstrually related migraine (MRM) is defined as occurring from days -2 to +3 of menstruation in at least 2 out of 3 menstrual cycles, and additionally at other times of the menstrual cycle. MRM is generally longer lasting, more severe, and more difficult to treat compared to non-MRM attacks. MAP0004 is an investigational orally inhaled dihydroergotamine (DHE) for the acute treatment of migraine. In a large Phase 3 study, MAP0004 was effective and well tolerated in treating an acute migraine attack compared to placebo. This post-hoc analysis compares the efficacy of MAP0004 in treating MRM versus non-MRM, including an analysis of recurrence rates using 4 different, previously published recurrence rate definitions. The efficacy of MAP0004, as measured by pain relief at 2 hours, pain free at 2 hours, sustained pain relief at 2-24 and 2-48 hours, and sustained pain free at 2-24 and 2-48 hours values, was not significantly different between subjects with MRM and non-MRM. Furthermore, the MRM recurrence rates after pain relief were not statistically higher than that of non-MRM treated with MAP0004. There were no significant differences in the frequency of adverse events for MRM vs. non-MRM subjects, and no drug-related serious adverse events were reported. In the study, MAP0004 was effective and well-tolerated for both MRM and non-MRM.

References

  1. Headache Classification Subcommittee of the International Headache Society: The international classification of headache disorders. Cephalalgia 2004., 24(suppl 1):

  2. Granella F, et al.: Characteristics of menstrual and nonmenstrual attacks in women with menstrually related migraine referred to headache centres. Cephalalgia 2004, 24(9):707–716. 10.1111/j.1468-2982.2004.00741.x

    CAS  Article  PubMed  Google Scholar 

  3. Sacco S, et al.: Migraine in women: the role of hormones and their impact on vascular diseases. J Headache Pain 2012, 13(3):177–89. Epub2012Feb26 10.1007/s10194-012-0424-y

    PubMed Central  CAS  Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Open Access This article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and Permissions

About this article

Cite this article

Aurora, S., Lu, B., Connors, E. et al. Analysis of subjects with menstrually related migraine vs. Non-menstrually related migraine treated with MAP0004. J Headache Pain 14 (Suppl 1), P143 (2013). https://doi.org/10.1186/1129-2377-14-S1-P143

Download citation

  • Published:

  • DOI: https://doi.org/10.1186/1129-2377-14-S1-P143

Keywords

  • Adverse Event
  • Placebo
  • Internal Medicine
  • Migraine
  • Recurrence Rate