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

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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

Baseline Characteristics

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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

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1. Primary:

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

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Measure Type	Primary
Measure Title	Number of Participants Who Are Pain Free at 2 Hours Post-Dose
Measure Description	Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose.
Time Frame	2 hours post-dose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS): The FAS population includes all randomized participants who have at least one assessment within 2 hours post-dose (i.e., after baseline assessment).

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

Measured Values

	Rizatriptan 10 mg ODT	Placebo
Number of Participants Analyzed [units: participants]	92	96
Number of Participants Who Are Pain Free at 2 Hours Post-Dose [units: Participants]	61	27

No statistical analysis provided for Number of Participants Who Are Pain Free at 2 Hours Post-Dose

2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In the Adverse Events section, all non-serious adverse experiences reported are post-treatment, up to the time of taking rescue medication or 14 days post-dose, whichever comes first.

Results Point of Contact:

Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc.
phone: 1-800-672-6372

Publications:

Cady RK, Martin VT, Géraud G, Rodgers A, Zhang Y, Ho AP, Hustad CM, Ho TP, Connor KM, Ramsey KE. Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response. Headache. 2009 May;49(5):687-96.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_547, MK0462-081
Study First Received:	August 13, 2007
Results First Received:	March 12, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00516737 History of Changes
Health Authority:	United States: Food and Drug Administration