Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit.

Reporting Groups

	Description
Rizatriptan 10 mg ODT	Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
Placebo	Matching placebo; one dose, treatment of a single migraine attack

Participant Flow:   Overall Study

	Rizatriptan 10 mg ODT	Placebo
STARTED	103	104
COMPLETED	92	96
NOT COMPLETED	11	8
Lost to Follow-up	2	0
Physician Decision	0	1
Withdrawal by Subject	0	1
Lack of Qualifying Event	9	6

1.  Primary:

Number of Participants Who Are Pain Free at 2 Hours Post-Dose   [ 2 hours post-dose ]

2.  Secondary:

Number of Participants With 24-Hour Sustained Pain Freedom   [ 24 hours post-dose ]

3.  Secondary:

Number of Participants With no Rescue Use up to 24 Hours Post-Dose   [ 24 hours post-dose ]

4.  Secondary:

Number of Participants With Absence of Photophobia at 2 Hours Post-dose   [ 2 hours post-dose ]

5.  Secondary:

Number of Participants With Absence of Phonophobia at 2 Hours Post-dose   [ 2 hours post-dose ]

6.  Secondary:

Number of Participants With Absence of Nausea at 2 Hours Post-dose   [ 2 hours post-dose ]

7.  Secondary:

Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose   [ 2 hours post-dose ]