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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  04/30/2009
 
Trade Name:  Axert
 
Generic or Proper Name (*):  almotriptan
 
Indications Studied:  Acute treatment of pediatric migraine in adolescent patients age 12-17 years
 
Therapeutic Category:  Antimigraine
 
Ages Studied:  12-17 years
 
Study #:  1
 
Study Type:  Efficacy
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  714
 
No Centers:  93
 
No Countries:  4
 
BPCA(B), PREA(P):  B
 
Asian:  2
 
Black:  121
 
Other:  28
 
White:  539
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  18
 
Hispanic/Latino:  179
 
Non-Hispanic/Non Latino:  531
 
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