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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/16/2011
 
Trade Name:  Maxalt and Maxalt-MLT
 
Generic or Proper Name (*):  rizatriptan
 
Indications Studied:  Treatment of migraine
 
Therapeutic Category:  Antimigraine
 
Ages Studied:  12-17 years
 
Study #:  3
 
Study Type:  Safety
 
Study Design:  Open Label
 
No Patients:  373
 
No Centers:  146
 
No Countries:  4
 
BPCA(B), PREA(P):  B
 
Asian:  1
 
Black:  38
 
Other:  11
 
White:  320
 
Unknown:  0
 
American Indian/Alaska Native:  3
 
Hispanic/Latino:  39
 
Non-Hispanic/Non Latino:  334
 
Countries:  US, Finland, Sweden, the Netherlands
 
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