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The Impact of Topiramate on Health-Related Quality of Life Indicators in Chronic Migraine

Authors

  • David W. Dodick MD,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Stephen Silberstein MD,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Joel Saper MD,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Fred G. Freitag DO,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Roger K. Cady MD,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Alan M. Rapoport MD,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Ninan T. Mathew MD,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Joseph Hulihan MD,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Concetta Crivera PharmD, MPH,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Marcia F.T. Rupnow PhD,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Lian Mao MS,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Gary Finlayson RPh,

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Steven J. Greenberg MD

    1. From the Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA (Dr. Dodick); Jefferson Headache Center, Philadelphia, PA, USA (Dr. Silberstein); Michigan Head Pain and Neurological Institute, Ann Arbor, MI, USA (Dr. Saper); Diamond Headache Clinic, Chicago, IL, USA (Dr. Freitag); Headache Care Center, Springfield, MO, USA (Dr. Cady); UCLA School of Medicine, Department of Neurology, Los Angeles, CA, USA (Dr. Rapoport); Houston Headache Clinic, Houston, TX, USA (Dr. Mathew); Ortho-McNeil Janssen, Scientific Affairs, LLC, Titusville, NJ, USA (Drs. Hulihan, Crivera, Rupnow, Mao, Finlayson, and Greenberg).
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  • Conflict of Interest:
    David W. Dodick is a consultant/advisor for Eli Lilly, GlaxoSmithKline, Merck, Neuralieve, Ortho-McNeil. He is involved in research studies with Advanced Bionics, AstraZeneca, Medtronic, and Alexza, for which his academic institution has received research grants. He is also the principal investigator of a multicenter clinical trial with St. Jude. He has no stock or equity in any pharmaceutical company.
    Stephen Silberstein has received personal compensation for activities with GlaxoSmithKline, Inc.; Johnson & Johnson; Merck & Co., Inc.; UCB Pharma; AstraZeneca Pharmaceuticals; Pfizer Inc.; Allergan, Inc.; Pozen, Inc.; Abbott Laboratories, Inc.; Eli Lilly & Company; NPS; and Xcel Pharmaceuticals. Dr. Silberstein has received personal compensation in an editorial capacity for Current Pain and Headache. Dr. Silberstein has received financial support for scholarly activities from GlaxoSmithKline, Inc.; Johnson & Johnson; Merck & Co., Inc.; Pfizer Inc.; Allergan, Inc.; and Abbott Laboratories, Inc.
    Joel Saper has received honoraria for speaking from GlaxoSmithKline; Merck & Co., Inc.; Abbott Laboratories, Inc.; Elan Corporation; AstraZeneca Pharmaceuticals; Pfizer Inc.; Ortho-McNeil Pharmaceuticals, Inc.; Bristol-Myers Squibb; Medtronic Inc.; Endo Pharmaceuticals; Advanced Bionics; Pozen, Inc.; and Penwest Pharmaceuticals Co. Dr. Saper has received personal compensation in an editorial capacity for Pain Watch and Migraine Monitor. He holds stock in Pozen, Inc. and has received research support from Novartis; Ortho-McNeil Pharmaceuticals, Inc; Merck & Co., Inc.; GlaxoSmithKline; Allergan, Inc.; Eisai Inc.; AstraZeneca Pharmaceuticals; Abbott; Advanced Bionics; Medtronic; Renovis; and Pozen, Inc.
    Fred G. Freitag has received personal compensation for activities with Allergan, Inc.; AstraZeneca Pharmaceuticals; Merck & Co., Inc.; Ortho-McNeil Pharmaceuticals, Inc.; Valeant Pharmaceuticals International; Pfizer Inc.; and GlaxoSmithKline, Inc. Dr. Freitag has received research support from Alzyer; AstraZeneca Pharmaceuticals; GlaxoSmithKline, Inc.; Merck & Co., Inc.; Ortho-McNeil Pharmaceuticals, Inc.; Advanced Bionics; Solvay S.A.; and Vernalis.
    Roger K. Cady has received personal compensation for activities with Allergan; Atrix Labs; Capnia; Endo; GlaxoSmithKline; Johnson & Johnson; Med Point; Merck; Ortho-McNeil Pharmaceuticals, Inc.; and Winston Labs. Dr. Cady received compensation from NIPC for serving as a co-editor of their migraine newsletter. Dr. Cady has received research support from Abbott; Allergan; Alexa; Aradigm Corp; Capnia; Cipher; Eisai Pharmaceuticals; Endo Pharmaceuticals; GelStat; GlaxoSmithKline; Johnson & Johnson; Matrixx; Merck; Ortho-McNeil Pharmaceuticals, Inc.; Pfizer Inc.; and Vernalis.
    Alan M. Rapoport has received personal compensation from the following pharmaceutical companies, advisory boards, speaker's bureau, research or educational grants: Abbott Laboratories; Allergan, Inc.; AstraZeneca; Eisai Pharmaceuticals; Endo Pharmaceuticals; Forest Laboratories; GlaxoSmithKline; Janssen Pharmaceuticals; Johnson & Johnson; MedPointe; Merck; Ortho-McNeil Pharmaceuticals, Inc.; Pfizer Inc.; UCB Pharma; Valeant; Vernalis; and Winston.
    Ninan T. Mathew has received personal compensation for activities with Eisai Pharmaceuticals.
    Joseph Hulihan, Concetta Crivera, Marcia F.T. Rupnow, Lian Mao, Gary Finlayson, and Steven J. Greenberg are employees of Ortho-McNeil Janssen Scientific Affairs, LLC.

Dr. David W. Dodick, Mayo Clinic College of Medicine, Department of Neurology, Scottsdale, AZ, USA.

Abstract

Background.— Chronic migraine is a disabling primary chronic daily headache disorder that significantly impacts the daily activities of patients with this disorder. To our knowledge, this is the first report of a large, randomized, double-blind, placebo-controlled trial that assessed the impact of topiramate on the daily activities, emotional distress, headache-related disability, and global impression of change in patients with chronic migraine.

Objective.— To assess whether topiramate 100 mg/day reduces migraine-related disability and limitations of daily activities in patients with chronic migraine.

Study Design/Methods.— Patients aged ≥18 years with chronic migraine were randomized 1 : 1 ratio to topiramate 100 mg/day or placebo. The double-blind period lasted 16 weeks. Three patient-reported outcome measures were administered: Migraine Disability Assessment, Migraine-Specific Quality of Life Questionnaire (Domains: Role Function Restrictive and Preventive and Emotional Function), and Subject's Global Impression of Change. Investigators completed a Physician's Global Impression of Change for each patient. Subject's Global Impression of Change and Physician's Global Impression of Change were completed one time, at the end of study, and measured on a 7-point scale (1 = very much improved to 7 = very much worse). The Migraine-Specific Quality of Life Questionnaire was analyzed using analysis of covariance (last observation carried forward) approach. Results were not adjusted for multiplicity.

Results.— A total of 328 patients were randomized (topiramate, n = 165; placebo, n = 163), and 306 patients were included in the intent-to-treat population. Mean age was 38.2 years, and a majority of the patients were female (85.3%). Fifty-six percent of topiramate-treated patients vs 45% of placebo-treated patients reported >50% improvement from baseline in Migraine Disability Assessment scores (P = .074). The Migraine-Specific Quality of Life Questionnaire analysis demonstrated significant improvements at week 4 in all 3 domains, and at weeks 8 and 16 in both Role Function – Restrictive and Emotional Function domains (P < .05). Role Function – Preventive approached, but did not reach significance, at week 8 (P = .053). Seventy-five percent and 72% of topiramate-treated patients vs 61% and 59% of placebo-treated patients reported improvements on the Subject and Physician's Global Impression of Change scales (P = .025 and P = .037, respectively).

Conclusion.— Compared with placebo-treated patients, topiramate 100 mg/day appears to contribute to reductions in migraine-related limitations on daily activities and emotional distress beginning as early as week 4 and continuing up to week 16 after treatment. Physician's Global Impression of Change results are very similar with Subject's Global Impression of Change, indicating concordance between the physician's and the subject's assessment of improvement.

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