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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 #:  2
 
Study Type:  Safety
 
Study Design:  Open Label
 
No Patients:  447
 
No Centers:  53
 
No Countries:  1
 
BPCA(B), PREA(P):  B
 
Asian:  0
 
Black:  0
 
Other:  0
 
White:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  185
 
Non-Hispanic/Non Latino:  531
 
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