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Efficacy of Zolmitriptan at Early Time-Points for the Acute Treatment of Migraine and Treatment of Recurrence

A Randomised, Placebo-Controlled Trial

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Abstract

Objective and Study Design: This double-blind, placebo-controlled trial assessed the efficacy of zolmitriptan versus placebo at early time-points post-dose as an acute treatment for migraine and treatment of headache recurrence.

Patients and Methods: Patients (18 to 65 years) with a ≥1-year history of migraine, age of onset <50 years and an average of 2 to 6 migraine headaches per month were recruited by 45 North American research clinics. 1017 patients were randomised to receive treatment for each of 3 migraine headaches of moderate or severe baseline intensity (labelled A, B and C, and given in a randomised order). Within each headache, patients were randomly allocated to different treatment regimens. Each patient treated each of the 3 headaches (A, B and C) with up to 3 doses, i.e. an initial dose (headache A, zolmitriptan 2.5mg or placebo; headache B, zolmitriptan 5mg or placebo; headache C, zolmitriptan 2.5mg), recurrence prevention 8 hours after initial dose [headache A and B, placebo (to maintain blind); headache C, zolmitriptan 2.5mg or placebo] and a recurrence treatment dose, if required (headache A and B, zolmitriptan 2.5mg or placebo; headache C, zolmitriptan 2.5mg). The 2 primary end-points were headache response rates 45 minutes after the initial dose of zolmitriptan 2.5 or 5mg or placebo, and headache response rates 2 hours after zolmitriptan 2.5mg or placebo for the treatment of recurrent headache, in patients responding at 4 hours to the initial dose.

Results: A total of 734 patients treated all 3 headaches. Headache response following an initial dose of zolmitriptan 2.5 and 5mg was significantly greater than placebo by 45 minutes (p < 0.001, p < 0.01, respectively) and was maintained at 1, 2 and 4 hours. Headache response following zolmitriptan treatment for recurrence was higher than that for placebo, but the difference did not reach statistical significance. A dose taken 8 hours after the initial dose did not appear to provide any benefit in preventing recurrent headache.

Conclusions: Zolmitriptan 2.5 and 5mg provides a rapid onset of action with significant relief of migraine headache by 45 minutes post-dose compared with placebo.

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Acknowledgements

This study was sponsored by Zeneca Pharmaceuticals.

We would like to thank the investigators who took part in this study: M. Alexander (Niagara Falls, Ontario, Canada); S.K. Aurora (Detroit, Michigan, USA); R.K. Bath (Cincinnati, Ohio, USA); W.J. Becker (Calgary, Alberta, Canada); S.D. Bleser (Bellbrook, Ohio, USA); D.W. Brown (Austin, Texas, USA); J.R. Caldwell (Daytona Beach, Florida, USA); J.R. Couch (Oklahoma City, Oklahoma, USA); J.D. Dexter (Columbia, Missouri, USA); S. Diamond (Chicago, Illinois, USA); A.P. Dietrich (Woodstock, Vermont, USA); V.A. Elinoff (Endwell, New York, USA); A.H. Elkind (Mount Vernon, New York, USA); J.A. Gezon (Salt Lake City, Utah, USA); R.A.M. Giammarco (Hamilton, Ontario, Canada); J. Goldstein (San Francisco, California, USA); R.K. Hippert (Fleetwood, Pennsylvania, USA); J.A. Holmes (Mission, Kansas, USA); J.T. Hormes (Marietta, Georgia, USA); C.M. Jackson (San Diego, California, USA); P.D. Kanof (Tucson, Arizona, USA); N.M. Kassman (Statesville, North Carolina, USA); A.E. Koff (Philadelphia, Pennsylvania, USA); S.J. Kolesk (Mt Laurel, New Jersey, USA); J.P. Levine (East Brunswick, New Jersey, USA); F.P. Maggiacomo (Cranston, Rhode Island, USA); N.T. Mathew (Houston, Texas, USA); A. Mauskop (Brooklyn, New York, USA); J.M. McCarty (Fresno, California, USA); R.B. Nett (San Antonio, Texas, USA); T.M. Nolen (Columbiana, Alabama, USA); P. Patel (Mississauga, Ontario, Canada); R.C. Reed (Cleveland, Ohio, USA); M.D. Reynolds (Dallas, Texas, USA); M.A. Rosemore (Hueytown, Alabama, USA); R.E. Ryan (Chesterfield, Missouri, USA); CH Sadowsky (West Palm Beach, Florida, USA); A. Shuaib (Saskatoon, Saskatchewan, Canada); C.F. Springgate (New Britain, Connecticut, USA); M.S. Touger (Birmingham, Alabama, USA); M.J. Weinstein (East Brunswick, New Jersey, USA); K.M.A. Welch (Detroit, Michigan, USA); T. Williams (Peoria, Arizona, USA); R.M. Willis (Harrogate, Tennessee, USA); M.C.B. Wilson (Tampa, Florida, USA); G.W. Wolfley (Scottsdale, Arizona, USA); and S. Zeig (Ft Lauderdale, Florida, USA).

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Authors and Affiliations

  1. Ryan Headache Center, 1585 Woodlake Drive, Suite 200, Chesterfield, Missouri, 63017, USA

    Robert E. Ryan Jr

  2. Diamond Headache Clinic, Chicago, Illinois, USA

    Seymour Diamond

  3. Practice of Neurology, Hamilton, Ontario, Canada

    Rose A. M. Giammarco

  4. Henry Ford Hospital, Detroit, Michigan, USA

    Sheena K. Aurora

  5. University Hospital, Cleveland, Ohio, USA

    Ronald C. Reed

  6. Zeneca Pharmaceuticals, Wilmington, Delaware, USA

    Pamela E. Fletcher

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  1. Robert E. Ryan Jr
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  4. Sheena K. Aurora
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  5. Ronald C. Reed
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Ryan, R.E., Diamond, S., Giammarco, R.A.M. et al. Efficacy of Zolmitriptan at Early Time-Points for the Acute Treatment of Migraine and Treatment of Recurrence. Mol Diag Ther 13, 215–226 (2000). https://doi.org/10.2165/00023210-200013030-00007

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  • DOI: https://doi.org/10.2165/00023210-200013030-00007

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