Zomig - Treatment of Acute Migraine Headache in Adolescents

Study Overview
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Brief Summary
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The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).

Official Title
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A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents

Conditions
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Migraine Headache

Intervention / Treatment
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* Drug: Placebo
* Drug: Zolmitriptan
* Drug: Zolmitriptan
* Drug: Zolmitriptan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures. Established diagnosis of migraine. History of a minimum of 2 migraine attacks (moderately or severely disabling)per month. Exclusion Criteria: Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments. A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache. Have had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug.

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Placebo<br>* Placebo nasal spray<br>|
| Experimental: 2<br>ZOMIG 0.5 mg | Drug: Zolmitriptan<br>* 0.5 mg nasal spray<br>* Other names: Zomig® Nasal Spray;|
| Experimental: 3<br>ZOMIG 2.5 mg | Drug: Zolmitriptan<br>* 2.5 mg nasal spray<br>* Other names: Zomig® Nasal Spray;|
| Experimental: 4<br>ZOMIG 5.0 mg | Drug: Zolmitriptan<br>* 5.0 mg nasal spray<br>* Other names: Zomig® Nasal Spray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-free Status at 2 Hours Post-treatment |  | 2 hours post-treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-free Status at 24 Hours Post-treatment |  | 24 hours post-treatment | 
| Headache Response at 2 Hours Post-treatment | Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment. | 2 hours post-treatment | 
| Headache Response at 24 Hours Post-treatment | Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment. | 24 hours post-treatment | 
| Sustained Headache Response at 2 Hours | Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment. | Up to 2 hours post-treatment | 
| Use of Rescue Medication During the First 24 Hours After Treatment |  | 24 hours post-treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Headache, Pain, Efficacy, Adolescents