TREXIMA (Currently Treximet) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1) - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Condition:	Migraine Disorders
Intervention:	Drug: sumatriptan succinate / naproxen sodium

	Placebo	Sumatriptan/Naproxen
STARTED	334	345
COMPLETED	245	243
NOT COMPLETED	89	102
Lost to Follow-up	23	23
Protocol Violation	2	12
Withdrawal by Subject	15	18
Sponsor terminated Study	0	1
Not eligible	6	7
No opportunity to treat headache	32	34
Not otherwise specified	11	7

Baseline Characteristics

Reporting Groups

	Description
Placebo	Baseline Characteristics used the Safety Population. Not the Randomised Population
Sumatriptan/Naproxen	Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population

Baseline Measures

	Placebo	Sumatriptan/Naproxen	Total
Number of Participants [units: participants]	246	254	500
Age [units: years] Mean ± Standard Deviation	36.6 ± 11.23	35.8 ± 11.47	36.2 ± 11.35
Gender [units: participants]
Female	176	195	371
Male	70	59	129
Race/Ethnicity, Customized [units: Participants]
African American/African Heritage	28	30	58
American Indian or Alaskan Native	1	0	1
Asian - East Asian Heritage	6	8	14
Asian - Japanese Heritage	2	1	3
Asian - South East Asian Heritage	8	5	13
Native Hawaiian or other Pacific Islander	1	0	1
White - Arabic/North African Heritage	1	2	3
White - White/Caucasian/European Heritage	199	206	405
Mixed race	0	1	1
Missing	0	1	1

Outcome Measures

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1. Primary:

Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. [ 2 hours through 24 hours after Treatment ]

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Measure Type	Primary
Measure Title	Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.
Measure Description	Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.
Time Frame	2 hours through 24 hours after Treatment
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.
The Intent to Treat (ITT) Population was the primary analysis population for assessing efficacy and included subjects who treated at least 1 headache attack with randomized treatment and provided at least one post dose evaluation.

Reporting Groups

	Description
Placebo	No text entered.
Sumatriptan/Naproxen	Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)

Measured Values

	Placebo	Sumatriptan/Naproxen
Number of Participants Analyzed [units: participants]	221	222
Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose. [units: Participants]
Pain-Free (2 hours)	25	64
Sustained Pain-Free (2-24 hours)	20	54

Statistical Analysis 1 for Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001
Percent difference ^[4]	18
95% Confidence Interval	( 10 to 25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Pain-Free (2 hours)
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Endpoints were co-primary and both needed to have p-value of <0.05 to be considered indicative of efficacy.
[4]	Other relevant estimation information:
	Analysis for Migraine Pain-Free at 2 hours Post-Dose

Statistical Analysis 2 for Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	<0.001
Percent difference ^[4]	15
95% Confidence Interval	( 8 to 22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Sustained Pain-Free (2-24 hours)
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	Analysis for Sustained Pain Free from 2-24 hours Post-dose

2. Secondary:

Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment [ 0.5, 1, and 4 hours after Treatment ]

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3. Secondary:

Sustained Headache Relief 2-24 Hours After Treatment [ 2-24 hours after treatment ]

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4. Secondary:

Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment [ 0.5, 1, 2, and 4 hours after treatment ]

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5. Secondary:

Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment [ 0 - 24 hours after treatment ]

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6. Secondary:

Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment [ 1-2, and 2- 4 hours after treatment ]

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7. Secondary:

Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours [ 1-2 and 2-4 hours after treatment ]

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8. Secondary:

Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment [ 2 and 4 hours after treatment ]

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9. Secondary:

Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score [ 0 - 24 hours after treatment ]

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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:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the Publication of results from all centers of a multi-center trial but requests that reports based on Single-site data not precede the primary publication of the entire clinical trial.

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
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Study ID Numbers:	TXA107563
Study First Received:	October 11, 2006
Results First Received:	February 19, 2009
Last Updated:	November 11, 2009
ClinicalTrials.gov Identifier:	NCT00387881 History of Changes
Health Authority:	United States: Food and Drug Administration