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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

Authors

  • Roger Cady MD,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Jim Banks MD,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Robert B. Nett MD,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Jerome Goldstein MD,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Nathan Bennett MD,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Ira M. Turner MD,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Gary E. Ruoff MD,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Stephen H. Landy MD,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Kathleen Farmer PsyD,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Márta Juhász MS, MSPH,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Jeanne Tarrasch RN,

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • M. Chris Runken PharmD

    1. From the Headache Care Center, Springfield, MO, USA (R. Cady and K. Farmer); Ryan Headache Center, St. Louis, MO, USA (J. Banks); Texas Headache Associates, San Antonio, TX, USA (R.B. Nett); San Francisco Headache Clinic, San Francisco, CA, USA (J. Goldstein); Headache Wellness Center, Pittsburgh, PA, USA (N. Bennett); Island Neurological Associates, Plainview, NY, USA (I.M. Turner); Westside Family Medical Center, Kalamazoo, MI, USA (G.E. Ruoff); Wesley Headache & Neurology Clinic, Memphis, TN, USA (S.H. Landy); Solor Consulting, LLC, Lysaker, Norway (M. Juhász); Clinvest/A Division of Banyan Group, Inc., Springfield, MO, USA (J. Tarrasch); GlaxoSmithKline, Inc., Research Triangle Park, NC, USA (M.C. Runken).
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  • Conflict of Interest: Dr. Roger Cady: Consultant for GlaxoSmithKline, Merck, Ortho-McNeil. Research grants from Allergan, Endo Pharmaceuticals, GlaxoSmithKline, Merck, Pozen, PuraMed Bioscience, and Wyeth. Dr. Jerome Goldstein has served as a consultant and/or advisory boards for GlaxoSmithKline as well as multiple pharmaceutical companies. Dr. James Banks, Dr. Robert Nett, Dr. Nathan Bennett, and Dr. Goldstein as investigators received research support from GlaxoSmithKline. Dr. Ira Turner has served as a consultant and/or speaker's bureau for Allergan, Astellas, GlaxoSmithKline, Merck, Merz Pharmaceuticals, Zogenix, and has received research support from Allergan, GlaxoSmithKline, Merck, NINDS, and NuPathe. Dr. Gary Ruoff has served on the speaker's bureau and as investigator received research grants from GlaxoSmithKline. Dr. Stephen Landy is on GlaxoSmithKline speaker's bureau and has been compensated for GSK related migraine research. Dr. Chris Runken is an employee of GlaxoSmithKline, Inc. Dr. Kathleen Farmer and Ms. Jeanne Tarrasch have nothing to disclose.

  • Financial support: Roger K. Cady, MD, sponsored this research through a grant from GlaxoSmithKline.

  • Clinical Trial Registration Number: NCT00893737.

R.K. Cady, Headache Care Center, 3805 S. Kansas Expressway, Springfield, MO 65807, USA. Email: rcady@banyangroupinc.com

Abstract

(Headache 2011;51:961-970)

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.

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