Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE

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.

Timeline

Start

2017-11-27

Primary completion

2020-07-02

Completion

2020-09-28

Drugs

Indications