At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,653 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Zolmitriptan 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Placebo and Zolmitriptan for Migraine Headache. Completed, enrolled 1,653 participants across 74 sites in 8 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Headache
CountriesEstonia, Finland, Hungary, Latvia, Poland, Serbia, Slovakia, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedSep 2010
Primary CompletionOct 2013
TodayJul 2026
First PostedSep 29, 2010
Enrollment StartSep 1, 2010
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.8 years ago
Interventions
Placebodrug
Placebo nasal spray
Zolmitriptandrug
0.5 mg nasal spray
Zolmitriptandrug
2.5 mg nasal spray
Zolmitriptandrug
5.0 mg nasal spray