Study identifier:D1220C00001
ClinicalTrials.gov identifier:NCT01211145
EudraCT identifier:N/A
CTIS identifier:N/A
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
Migraine Headache
Phase 4
No
Placebo, Zolmitriptan
All
1653
Interventional
12 Years - 17 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2016 by AstraZeneca
AstraZeneca
-
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).
Location
Location
Tallinn, Estonia
Location
Tartu, Estonia
Location
Helsinki, Finland
Location
Mikkeli, Finland
Location
Turku, Finland
Location
Budapest, Hungary
Location
Debrecen, Hungary
Location
Gyula, Hungary
Arms | Assigned Interventions |
---|---|
Placebo Comparator: 1 Placebo | Drug: Placebo Placebo nasal spray |
Experimental: 2 ZOMIG 0.5 mg | Drug: Zolmitriptan 0.5 mg nasal spray Other Name: Zomig® Nasal Spray |
Experimental: 3 ZOMIG 2.5 mg | Drug: Zolmitriptan 2.5 mg nasal spray Other Name: Zomig® Nasal Spray |
Experimental: 4 ZOMIG 5.0 mg | Drug: Zolmitriptan 5.0 mg nasal spray Other Name: Zomig® Nasal Spray |
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