NCT03275922

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Placebo ZNS	Placebo Zolmitriptan Nasal Spray
DRUG	ZNS	Zolmitriptan Nasal Spray

Timeline

• Start date: 2017-11-27
• Primary completion: 2020-07-02
• Completion: 2020-09-28
• First posted: 2017-09-08
• Last updated: 2021-01-11

Locations

47 sites across 1 country: United States

Regulatory

• FDA-regulated drug study