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Efficacy & Safety of Zolmitriptan Nasal Spray

Efficacy & Safety of Zolmitriptan Nasal Spray for Acute Migraine Treatment in 6 to 11 year olds

Description:

For complete study details, please visit the study on clinicaltrials.gov.

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.
Interested in participating?
We are currently recruiting
Study Sponsor:

IMPAX Laboratories, Inc.

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
If you are interested in this study or have questions about your child's eligibility, please contact:

Rebecca D. Considine Research Institute, 330-543-3193 or email research@akronchildrens.org

Lead Investigator
M. Cristina Victorio, MD

Director, Headache Program; Pediatric Neurologist
Pediatric NeurologyNeuroDevelopmental Science CenterHeadache Clinic