Efficacy determined by patient 2 hours after dosing by rating of headache intensity as a decrease from moderate or severe to mild or no pain
Efficacy, symptoms, headache pain free at time points 0.25, 0.5, 1, 1.5 hours postdose; incidence of headache recurrence in 2 to 24 hours and use of rescue medication 2 to 24 hours postdose; pain relief or pain free at 24 hours; all by patient assessment
12 Years to 17 Years (Child)
September 21, 2005
May 17, 2011
† Study has passed its completion date and status has not been verified in more than two years.