Study to Test Rizatriptan in the Early Treatment of Acute Migraine

This study has been completed.

Study NCT00516737 Information provided by Merck

First Received: August 13, 2007 Last Updated: July 7, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Condition:	Migraine
Interventions:	Drug: Comparator: rizatriptan benzoate Drug: Comparator: Placebo

Participant Flow

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

Baseline Characteristics

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

Baseline Measures

	Rizatriptan 10 mg ODT	Placebo	Total
Number of Participants [units: participants]	103	104	207
Age [units: years] Mean ( Full Range )	41 ( 19 to 69 )	44 ( 18 to 66 )	42.5 ( 18 to 69 )
Gender [units: participants]
Female	90	96	186
Male	13	8	21
Race/Ethnicity, Customized [units: participants]
Black or African American	4	3	7
White	95	100	195
Asian	2	1	3
Multi-Racial	2	0	2

Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7