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Allodynia-Associated Symptoms, Pain Intensity and Time to Treatment: Predicting Treatment Response in Acute Migraine Intervention

Authors

  • Roger K. Cady MD,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); Diamond Headache Clinic, Ltd., Chicago, IL, USA (F.G. Freitag); Houston Headache Clinic, Houston, TX, USA (N.T. Mathew); Elkind Headache Center, Mount Vernon, NY, USA (A.H. Elkind); Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA (L. Mao, A.C. Fisher, D.M. Biondi, G. Finlayson, and J. F. Hulihan); EMD Serono, Inc., Rockland, MA, USA (S.J. Greenberg).
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  • Frederick G. Freitag DO,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); Diamond Headache Clinic, Ltd., Chicago, IL, USA (F.G. Freitag); Houston Headache Clinic, Houston, TX, USA (N.T. Mathew); Elkind Headache Center, Mount Vernon, NY, USA (A.H. Elkind); Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA (L. Mao, A.C. Fisher, D.M. Biondi, G. Finlayson, and J. F. Hulihan); EMD Serono, Inc., Rockland, MA, USA (S.J. Greenberg).
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  • Ninan T. Mathew MD,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); Diamond Headache Clinic, Ltd., Chicago, IL, USA (F.G. Freitag); Houston Headache Clinic, Houston, TX, USA (N.T. Mathew); Elkind Headache Center, Mount Vernon, NY, USA (A.H. Elkind); Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA (L. Mao, A.C. Fisher, D.M. Biondi, G. Finlayson, and J. F. Hulihan); EMD Serono, Inc., Rockland, MA, USA (S.J. Greenberg).
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  • Arthur H. Elkind MD,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); Diamond Headache Clinic, Ltd., Chicago, IL, USA (F.G. Freitag); Houston Headache Clinic, Houston, TX, USA (N.T. Mathew); Elkind Headache Center, Mount Vernon, NY, USA (A.H. Elkind); Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA (L. Mao, A.C. Fisher, D.M. Biondi, G. Finlayson, and J. F. Hulihan); EMD Serono, Inc., Rockland, MA, USA (S.J. Greenberg).
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  • Lian Mao PhD,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); Diamond Headache Clinic, Ltd., Chicago, IL, USA (F.G. Freitag); Houston Headache Clinic, Houston, TX, USA (N.T. Mathew); Elkind Headache Center, Mount Vernon, NY, USA (A.H. Elkind); Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA (L. Mao, A.C. Fisher, D.M. Biondi, G. Finlayson, and J. F. Hulihan); EMD Serono, Inc., Rockland, MA, USA (S.J. Greenberg).
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  • Alan C. Fisher DrPH,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); Diamond Headache Clinic, Ltd., Chicago, IL, USA (F.G. Freitag); Houston Headache Clinic, Houston, TX, USA (N.T. Mathew); Elkind Headache Center, Mount Vernon, NY, USA (A.H. Elkind); Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA (L. Mao, A.C. Fisher, D.M. Biondi, G. Finlayson, and J. F. Hulihan); EMD Serono, Inc., Rockland, MA, USA (S.J. Greenberg).
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  • David M. Biondi DO,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); Diamond Headache Clinic, Ltd., Chicago, IL, USA (F.G. Freitag); Houston Headache Clinic, Houston, TX, USA (N.T. Mathew); Elkind Headache Center, Mount Vernon, NY, USA (A.H. Elkind); Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA (L. Mao, A.C. Fisher, D.M. Biondi, G. Finlayson, and J. F. Hulihan); EMD Serono, Inc., Rockland, MA, USA (S.J. Greenberg).
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  • Gary Finlayson RPh,

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    • *

      Affiliation at time of study. Current affiliation is Johnson & Johnson Pharmaceutical Research & Development, LLC.

  • Steven J. Greenberg MD,

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); Diamond Headache Clinic, Ltd., Chicago, IL, USA (F.G. Freitag); Houston Headache Clinic, Houston, TX, USA (N.T. Mathew); Elkind Headache Center, Mount Vernon, NY, USA (A.H. Elkind); Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA (L. Mao, A.C. Fisher, D.M. Biondi, G. Finlayson, and J. F. Hulihan); EMD Serono, Inc., Rockland, MA, USA (S.J. Greenberg).
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  • Joseph F. Hulihan MD

    1. From the Headache Care Center, Springfield, MO, USA (R.K. Cady); Diamond Headache Clinic, Ltd., Chicago, IL, USA (F.G. Freitag); Houston Headache Clinic, Houston, TX, USA (N.T. Mathew); Elkind Headache Center, Mount Vernon, NY, USA (A.H. Elkind); Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA (L. Mao, A.C. Fisher, D.M. Biondi, G. Finlayson, and J. F. Hulihan); EMD Serono, Inc., Rockland, MA, USA (S.J. Greenberg).
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  • Financial support: Supported by Ortho-McNeil Janssen Scientific Affairs, LLC.

  • Conflict of Interest: Dr. Cady has served as a consultant for Aradigm Corp, GSK, Jazz Pharmaceuticals, Merck, and Ortho-McNeil Neurologics. He has served on advisory boards for Allergan, Atrix Laboratories, Inc., Capnia Inc., Endo Pharmaceuticals, Inc., GSK, Med-Pointe, Merck, and Ortho-McNeil Neurologics. He has received research grants from Advanced Bionics, Alizyme, Allergan, Alexza, BioAlliance, Capnia Inc., Forest Pharmaceuticals, GSK, Jazz Pharmaceuticals, King Pharmaceuticals, MAP Pharmaceuticals, Merck, Minster Pharmaceuticals, Neuralieve, Novartis, Ortho-McNeil Neurologics, Pfizer, Schwarz Biosciences, Torrey Pines Therapeutics, Wyeth, and Zogenix. Dr. Freitag has conducted research for Advanced Bionics, AstraZeneca, GlaxoSmithKline, Merck and Co., and Ortho-McNeil Neurologics. He has served as a consultant to Allergan, AstraZeneca, Capnia, Endo, Merck and Co., NuPathe, Ortho-McNeil Pharmaceuticals, Valeant Pharmaceuticals, and Zogenix Corporation. He has served on the speaker's bureau of GlaxoSmithKline, Merck and Co., Ortho-McNeil Pharmaceuticals, and Valeant Pharmaceuticals. He is on the board of directors for the National Headache Foundation and the Diamond Headache Clinic Research and Educational Foundation. He holds no significant financial positions in any pharmaceutical or medical device company. Dr. Mathew has served on advisory boards and speakers bureau for Allergan, Eisai, GSK, Merck, Ortho-McNeil, Pfizer, and has received financial support from Abbott, Allergan, Eisai, GSK, Merck, Ortho-McNeil, and Pfizer. Dr. Elkind has received grants, travel expenses for meetings, conducted clinical research, lectured and been on advisory boards for AstraZeneca, Endo Labs, GlaxoSmithKline, Merck, Ortho-McNeil, and Pfizer. Drs. Mao, Fisher, Biondi, Finlayson, and Hulihan are employees of Ortho-McNeil Janssen Scientific Affairs, LLC. Dr. Greenberg was also an employee of Ortho-McNeil Janssen Scientific Affairs, LLC, at the time of the development of this manuscript. He is currently an employee of EMD Serono.

R.K. Cady, Headache Care Center, 3805 S. Kansas Expressway, Springfield, MO 65807, USA.

Abstract

Objective.— To evaluate the relationship between treatment outcomes and allodynia-associated symptoms (AAS) at the time of treatment with almotriptan.

Methods.— Analyses were performed with data collected prospectively from patients in 2 recently completed early intervention trials, AXERT® Early miGraine Intervention Study (AEGIS) and AXERT® 12.5 mg time vs Intensity Migraine Study (AIMS): 2-hour pain free, 2-hour pain relief (AEGIS only), sustained pain free (SPF), use of rescue medication, and median headache duration (AIMS only), in the presence and absence of pretreatment AAS, which was determined by responses to a questionnaire. Analyses were conducted to evaluate possible prognostic variables.

Results.— The presence of pretreatment AAS did not have a significant effect on 2-hour pain-free, 2-hour pain-relief or SPF rates, use of rescue medication, or headache duration. Significant factors for most favorable outcomes (greater 2-hour pain-free, 2-hour pain-relief and SPF rates, less use of rescue medication, and shorter headache duration) included treatment with almotriptan 12.5 mg, treatment of mild or moderate headache pain, and treatment within 1 hour of headache onset.

Conclusion.— Almotriptan 12.5 mg was efficacious in providing 2-hour pain free, 2-hour pain relief, SPF, and reducing rescue medication use irrespective of the presence of AAS at the time of treatment. The most optimal efficacy outcomes occurred when patients treated migraine attacks early and before the onset of severe pain. The presence of AAS, which may indicate an early phase of allodynia, did not influence the efficacy of almotriptan therapy.

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