Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents

Study Overview
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Brief Summary
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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

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 2-Way Crossover Study With Single-Blind, Placebo-Challenge Evaluating the Efficacy of Zolmitriptan (Zomig) Nasal Spray 5mg, in the Treatment of Acute Migraine Headache in Adolescents.

Conditions
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Migraine

Intervention / Treatment
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* Drug: Zolmitriptan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Zolmitriptan<br>* 5mg nasal spray<br>* Other names: Zomig;|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache response and pain-free response to treatment |  | 15 minutes, 30 minutes, 45 minutes, 1.5 hours and 2 hours after randomized treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event reports |  | Four times within 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zolmitriptan, ZOMIG, migraine, headache response, headache, headache pain