Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
Status:
Completed
Trial end date:
2020-09-28
Target enrollment:
Participant gender:
Summary
To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment
of migraine headache in subjects ages 6 to 11 years.
Part 1: Approximately 20 weeks (includes screening and double-blind treatment).
- Screening will be performed based on the inclusion exclusion criteria specified in the
study protocol.
- Randomize approximately 288 subjects into the double-blind crossover phase.
Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter
part 2, a 6 month open-label safety extension (OLE).
Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in
both the double-blind and the OLE.