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Long-Term Use of Sumatriptan Nasal Spray is
Well-Tolerated in Adolescent Migraineurs
Shankar Natarajan, JT Jabbour, etal.
Posted: January 2003
Presented at: AHS Conference , Seattle WA, June 21-23, 2002
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Objective: To substantiate the long-term safety and tolerability of sumatriptan nasal spray (SNS) in an adolescent population of migraineurs aged 12 -17 years.
Methods:
- In this open-label, multicenter, observational study, adolescent migraineurs 12-17 years treated an unlimited number of migraine attacks meeting IHS criteria for up to 12 months with SNS.
- Eligible subjects must have had an average of at least 2 migraine attacks per month in each of the 2 months prior to study entry and a typical attack duration of approximately 4 hours or more.
- All subjects started treatment with the 20 mg. dose of SNS; a dosage decrease to 5 mg. may have been made at the investigator’s discretion in order to optimize a subject’s tolerability and efficacy needs.
- A second dose of study drug was permitted for subjects who attained complete or partial relief 2 hours after initial dosing and then experienced a recurrent or worsening of pain.
- Adverse events were assessed during monthly phone calls and during study visits, which occurred at 3-month intervals.
- An ECG, laboratory evaluations, and physical examination were performed at study entry and at the final study visit; an intranasal exam was performed mid-treatment and at the final study visit.
- Efficacy data, including migraine severity and recurrence, were collected from subjects approximately 24 hours after theintial treatment of every migraine attack.
- Subjects had not participated in previous long-term safety and/or efficacy studies of SNS.
Conclusions: Sumatriptan nasal spray 20 mg. was shown to be well-tolerated and efficacious during long-term use by adolescent migraineurs aged 12 to 17 years.
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