Last updated on June 2019

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

Brief description of study

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.

Clinical Study Identifier: NCT03275922

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Blue Sky Neurology (106)

Englewood, CO United States
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Precision Clinical Research, LLC. (135)

Lauderdale Lakes, FL United States
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Axcess Medical Research (126)

Loxahatchee Groves, FL United States
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Laszlo J. Mate, M.D., P.A. (153)

North Palm Beach, FL United States
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East Florida Research (143)

Port Saint Lucie, FL United States
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Mercy Research (116)

Saint Louis, MO United States
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Granger Medical Holladay (111)

Salt Lake City, UT United States
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Marshfield Clinic (145)

Marshfield, WI United States
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Recruitment Status: Open

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