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Study TXA 107977
“Trexema”
GlaxoSmithKlein
Enrollment:
July1-December 31, 2007
Length of Study: up to 12 months of
observation
Medication: Trexema – a combination of
sumatriptan (85 mg) and naproxen sodium
(500 mg)
Patient population: adolescents ages
12-17
Rational:
Currently, 4-10% of adolescents suffer
from migraine, no drugs approved for acute treatment for this age
Primary objective of study: to determine
safety and tolerability
Secondary objectives of study: (1) to
evaluate the efficacy of the Combination tablet (2) to assess quality of
life and productivity before and after use of medication for acute migraine
Design: Open-label, single-arm,
multi-center trial
Please call our office and ask for Dr.
Latimer if
you are interested in having your child be a candidate for our study or
email her at Latimer@washingtonheadaches.com Please leave a name and number so that a
call can be returned. |