Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents
Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents
The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig)
 nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a
 3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches
Inclusion Criteria:

 -  Adolescents aged 12-17 years at the time of screening. Patients must not be enrolled
 if they will turn 18 years of age within 12 weeks after randomization.

 -  An established diagnosis of migraine for at least 1 year; a minimum of 2 migraines,
 considered to be moderately/severely disabling, per month on average during the school
 year

 -  A history of usual migraine duration of >2-hours untreated for the 3 month prior to
 screening

 Exclusion Criteria:

 -  A history of basilar, ophthalmoplegic or hemiplegic migraine headache or any
 potentially serious neurological condition that is associated with headache or
 clinically significant abnormalities indicated from the medical history, physical exam
 etc

 -  Has used monoamine oxidase inhibitor-A (MAO-A), methysergide, methylergonovine or
 cimetidine in the 2 weeks before randomization.

 -  Evidence of ischemic heart disease, arrhythmia, accessory conduction pathway disorder
 as determined by central cardiologist using predetermined and agreed upon pediatric
 standards; Has uncontrolled hypertension