Status:
COMPLETED
Efficacy of Zolmitriptan (Zomig) in the Treatment of Migraines in Adolescents
Lead Sponsor:
Impax Laboratories, LLC
Conditions:
Migraine
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig) nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a 3-month period ...
Eligibility Criteria
Inclusion
- Adolescents aged 12-17 years at the time of screening. Patients must not be enrolled if they will turn 18 years of age within 12 weeks after randomization.
- An established diagnosis of migraine for at least 1 year; a minimum of 2 migraines, considered to be moderately/severely disabling, per month on average during the school year
- A history of usual migraine duration of \>2-hours untreated for the 3 month prior to screening
Exclusion
- A history of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache or clinically significant abnormalities indicated from the medical history, physical exam etc
- Has used monoamine oxidase inhibitor-A (MAO-A), methysergide, methylergonovine or cimetidine in the 2 weeks before randomization.
- Evidence of ischemic heart disease, arrhythmia, accessory conduction pathway disorder as determined by central cardiologist using predetermined and agreed upon pediatric standards; Has uncontrolled hypertension
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00617695
Start Date
September 1 2003
End Date
October 1 2004
Last Update
October 2 2024
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