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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
374
Placebo Zolmitriptan Nasal Spray
Zolmitriptan Nasal Spray
Phoenix Children's Hospital (149)
Phoenix, Arizona, United States
Arkansas Children's Hospital (109)
Little Rock, Arkansas, United States
Advanced Research Center, Inc (134)
Anaheim, California, United States
Sierra Medical Research (124)
Fresno, California, United States
Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119)
Sacramento, California, United States
Pain-free status at 2 hours post treatment
Headache pain intensity is assessed by the subjects immediately prior to treatment and 2 hours post-dose using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).
Time frame: 2 hours post-dose
Proportion of subjects who achieve pain-free status at 24 hours post-dose
The headache pain intensity is assessed by the subjects using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).
Time frame: 24 hours post-dose
Headache response at 24 hours post-dose
The subject diary captures the headache severity using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0). Headache response is defined as a reduction in moderate (2) or severe (3) pain to mild (1) or no (0) pain at 24 hour post-dose.
Time frame: 24 hours post-dose
Sustained headache response at 24 hours post-dose
Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none at 2 hours which is then maintained (without a return to moderate or severe pain) at 24 hours with no use of rescue medication prior to the 24 hour assessment.
Time frame: 24 hours post-dose
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Children's Hospital Colorado (154)
Aurora, Colorado, United States
Blue Sky Neurology (106)
Englewood, Colorado, United States
IMMUNOe Research Centers (150)
Thornton, Colorado, United States
Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)
Stamford, Connecticut, United States
Children's National Health System (141)
Washington D.C., District of Columbia, United States
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