Zolmitriptan Nasal Spray for Acute Migraine Treatment in 6 to 11 year olds
Full IRB Study Title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Efficacy And Safety Of Zolmitriptan Nasal Spray For The Treatment Of Acute Migraine In Subjects Ages 6 To 11 Years, With An Open-Label Extension
IRB Study ID: IPX229-B16-01
For complete study details, please visit the study on clinicaltrials.gov.
Study Sponsor:
IMPAX Laboratories, Inc.
Who May Qualify:
Pediatric patients between 6 to 11 years old who have been diagnosed with migraines may be eligible to participate if:
- They have migraines occurring at least 2 times per month with each episode lasting at least 3 hours.
- They experience at least 16 headache-free days per month on average.
Who Does NOT Qualify:
Patients are not eligible to participate if:
- They had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans
- They have previously used any nasal spray (triptan or dihydroergotamine) for the acute treatment of migraine
- They have a disease or medical condition which would exclude them from the study.
Lead Investigator
M. Cristina Victorio, MD
Director, Headache Program; Pediatric Neurologist
NeuroDevelopmental Science CenterHeadache ClinicPediatric Neurology