Long-Term, Open-Label Safety Study of Oral Almotriptan 12.5 mg for the Acute Treatment of Migraine in Adolescents

Authors

  • Frank Berenson MD,

    1. From the Child Neurology Associates, PC, Atlanta, GA, USA (F. Berenson); Neuro Network Partners/Miami Children's Hospital, Miami, FL, USA (E. Vasconcellos); Nationwide Children's Research Institute, Columbus, OH, USA (A. Pakalnis); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D.M. Biondi, and R.B. Armstrong).
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  • Elza Vasconcellos MD,

    1. From the Child Neurology Associates, PC, Atlanta, GA, USA (F. Berenson); Neuro Network Partners/Miami Children's Hospital, Miami, FL, USA (E. Vasconcellos); Nationwide Children's Research Institute, Columbus, OH, USA (A. Pakalnis); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D.M. Biondi, and R.B. Armstrong).
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  • Ann Pakalnis MD,

    1. From the Child Neurology Associates, PC, Atlanta, GA, USA (F. Berenson); Neuro Network Partners/Miami Children's Hospital, Miami, FL, USA (E. Vasconcellos); Nationwide Children's Research Institute, Columbus, OH, USA (A. Pakalnis); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D.M. Biondi, and R.B. Armstrong).
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  • Lian Mao PhD,

    1. From the Child Neurology Associates, PC, Atlanta, GA, USA (F. Berenson); Neuro Network Partners/Miami Children's Hospital, Miami, FL, USA (E. Vasconcellos); Nationwide Children's Research Institute, Columbus, OH, USA (A. Pakalnis); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D.M. Biondi, and R.B. Armstrong).
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  • David M. Biondi DO,

    1. From the Child Neurology Associates, PC, Atlanta, GA, USA (F. Berenson); Neuro Network Partners/Miami Children's Hospital, Miami, FL, USA (E. Vasconcellos); Nationwide Children's Research Institute, Columbus, OH, USA (A. Pakalnis); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D.M. Biondi, and R.B. Armstrong).
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  • Robert B. Armstrong MD

    1. From the Child Neurology Associates, PC, Atlanta, GA, USA (F. Berenson); Neuro Network Partners/Miami Children's Hospital, Miami, FL, USA (E. Vasconcellos); Nationwide Children's Research Institute, Columbus, OH, USA (A. Pakalnis); Ortho-McNeil Janssen Scientific Affairs, Titusville, NJ, USA (L. Mao, D.M. Biondi, and R.B. Armstrong).
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  • Financial support: Ortho-McNeil Janssen Scientific Affairs, LLC sponsored this trial.

  • Conflict of Interest: Frank Berenson: Speaker's bureaus for Glaxo-Smith-Kline, Ortho-McNeil, and UCB Pharma; clinical trial support from Allergan, Glaxo-Smith-Kline and Valeant Pharmaceuticals. Ann Pakalnis: Received research grant support from Glaxo-Smith-Kline and Ortho-McNeil. Elza Vasconcellos: no conflict. Lian Mao, David Biondi, and Robert Armstrong: Employees of Ortho-McNeil Janssen Scientific Affairs.

F. Berenson, Child Neurology, Associates, PC, 5505 Peachtree Dunwoody Road, Suite 500, Atlanta, GA 30342, USA.

Abstract

(Headache 2010;50:795-807)

Objectives.— This study evaluated the long-term safety of oral almotriptan 12.5 mg for the treatment of multiple migraine episodes in adolescents over a 12-month period. Efficacy outcomes were assessed as a secondary objective.

Methods.— Adolescent migraineurs aged 12-17 years were enrolled in this 12-month, open-label study (Study ID CR002827). Patients were instructed to record their assessments on paper headache records whenever they experienced a migraine headache that they treated with study medication. Safety was assessed descriptively and assessments included adverse event (AE) recording, change in laboratory values, vital signs, and electrocardiogram parameters. Efficacy outcomes were assessed descriptively and outcomes included rates for 2- and 24-hour pain relief and sustained pain relief, 2- and 24-hour pain-free and sustained pain-free, and presence of migraine-associated symptoms of photophobia, phonophobia, nausea and vomiting.

Results.— Overall, 67.1% of patients reported ≥1 AE over the course of the trial, 7.6% had an AE judged by the study investigator to be related to treatment with almotriptan, 2.4% discontinued because of an AE, and 1.9% reported serious AEs. The most commonly reported treatment-related AEs (occurring in ≥1% of patients) were nausea (1.4%) and somnolence (1.4%). Pain relief responses for treated migraines of moderate or severe intensity at baseline were 61.7% and 68.6%, at 2 and 24 hours, respectively; the sustained pain relief rate was 55.5%. Pain-free responses were reported for 40.5% of all treated migraines at 2 hours and 65.9% of treated migraines at 24 hours; the sustained pain-free rate was 38.4%. The proportion of migraines that achieved the pain relief, sustained pain relief, pain-free and sustained pain-free endpoints were similar in the 12- to 14-year and 15- to 17-year age groups. Treating with almotriptan 12.5 mg when headache pain was mild was associated with higher rates of pain relief and pain-free at 2 and 24 hours, and sustained pain relief and sustained pain-free, compared with treatment initiated when pain was severe.

Conclusions.— Almotriptan 12.5 mg was well tolerated in this adolescent population over a 12-month period. No unexpected safety or tolerability concerns were revealed over the course of this study. The results are consistent with almotriptan 12.5 mg being effective for the acute treatment of pain and symptoms associated with migraine in both younger and older adolescents.

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