drugset / Trial / NCT01211145
Zomig - Treatment of Acute Migraine Headache in Adolescents
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zolmitriptan | Small molecule | 0.5 mg | Intranasal |
| Subject | Zolmitriptan | Small molecule | 2.5 mg | Intranasal |
| Subject | Zolmitriptan | Small molecule | 5 mg | Intranasal |