drugset / Trial / NCT01211145

Zomig - Treatment of Acute Migraine Headache in Adolescents

NCT01211145 ↗

Phase 4 Completed 1653 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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).

Timeline

Start
2010-09
Primary completion
2013-10
Completion
2013-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs ZOMIG 5 mg; p <.001; Odds Ratio (OR) 2.18 (95% CI 1.40 to 3.39); Regression, Logistic; note: Unadjusted NCT01211145 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Zolmitriptan Small molecule 0.5 mg Intranasal
Subject Zolmitriptan Small molecule 2.5 mg Intranasal
Subject Zolmitriptan Small molecule 5 mg Intranasal

Indications