Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Migraine Disorders
Intervention:	Drug: Combination Tablet of Treximet (sumatriptan/naproxen sodium)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
85 mg Sumatriptan/500 mg Naproxen Sodium	Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium. A single Combination Tablet was supplied for each migraine attack, not to exceed one tablet in 24 hours.

Participant Flow: Overall Study

	85 mg Sumatriptan/500 mg Naproxen Sodium
STARTED	656
COMPLETED	363
NOT COMPLETED	293
Adverse Event	41
Lost to Follow-up	44
Protocol Violation	32
Withdrawal by Subject	106
Lack of Efficacy	28
Did not meet criteria for treatment	30
Postive drug screen	1
Withdrawn per medical monitor decision	2
Investigator decision	1
Participant had too few migraines	5
Increase in number of migraines	2
Increased use of concomitant medication	1

Baseline Characteristics

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Reporting Groups

	Description
85 mg Sumatriptan/500 mg Naproxen Sodium	Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.

Baseline Measures

	85 mg Sumatriptan/500 mg Naproxen Sodium
Number of Participants [units: participants]	622
Age ^[1] [units: Years] Mean ± Standard Deviation	14.7 ± 1.68
Gender [units: Participants]
Female	367
Male	255
Race/Ethnicity, Customized [units: participants]
Caucasian	527
Africian American	71
American Indian or Alaskan Native	10
Asian	4
African American/African Heritage and Asian	2
African American/African Heritage and White	3
American Indian or Alaskan Native and White	5

[1]	Baseline data were collected in the Safety Population, comprised of all participants in the Enrolled Population (all participants entered into the trial and categorized as "started" in the Participant Flow module) who took at least one dose of study drug.

Outcome Measures

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1. Primary:

Number of Participants With the Indicated Drug-related Adverse Events [ Time Frame: Baseline through End of Study (up to Month 12) ]

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2. Secondary:

Number of Participants With Any Adverse Event Categorized by Severity [ Time Frame: Baseline through End of Study (up to Month 12) ]

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3. Secondary:

Number of Participants With Any Adverse Event Categorized Over Time [ Time Frame: Baseline through End of Study (up to Month 12) ]

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4. Secondary:

Number of Participants With Any Adverse Event Categorized by Participant Age [ Time Frame: Baseline through End of Study (up to Month 12) ]

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5. Secondary:

Number of Participants With Any Adverse Event Categorized by Participant Race [ Time Frame: Baseline through End of Study (up to Month 12) ]

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6. Secondary:

Number of Participants With Any Adverse Event Categorized by Participant Gender [ Time Frame: Baseline through End of Study (up to Month 12) ]

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7. Secondary:

Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]

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8. Secondary:

Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]

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9. Secondary:

Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit [ Time Frame: Baseline through End of Study (up to Month 12) ]

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10. Secondary:

Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit [ Time Frame: Baseline through End of Study (up to Month 12) ]

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11. Secondary:

Mean Height for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]

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12. Secondary:

Mean Weight for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]

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13. Secondary:

Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]

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14. Secondary:

Mean Blood Pressure for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]

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15. Secondary:

Mean Heart Rate for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]

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16. Secondary:

Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator [ Time Frame: Screening and Final Visit (up to Month 12) ]

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17. Secondary:

Number of Treated Migraine Attacks [ Time Frame: Baseline through End of Study (up to Month 12) ]

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18. Secondary:

Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]

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19. Secondary:

Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]

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20. Secondary:

Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]

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21. Secondary:

Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month [ Time Frame: Baseline through End of Study (up to Month 12) ]

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22. Secondary:

Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]

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23. Secondary:

Number of Migraine Attacks Rated With the Indicated Pain Severity [ Time Frame: Baseline through End of Study (up to Month 12) ]

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24. Secondary:

Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting [ Time Frame: Baseline through End of Study (up to Month 12) ]

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25. Secondary:

Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12 [ Time Frame: Baseline and Months 3, 6, 9, and 12 ]

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26. Secondary:

Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire–Revised (PPMQ-R) at the Screening Visit [ Time Frame: Screening ]

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27. Secondary:

Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire–Revised (PPMQ-R) at Month 12 [ Time Frame: End of Study/Month 12 ]

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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
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Results Point of Contact:

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

Publications of Results:

McDonald SA, Hershey AD, Pearlman EM, Winner PK, Rothner DA, Linder SL, Richard NE, Derosier FJ. Long-term safety and tolerability of a single, fixed-dose tablet of sumatriptan and naproxen sodium (SumaRT/Nap) in adolescent migraineurs. Headache. 2010; 48.

Publications automatically indexed to this study:

McDonald SA, Hershey AD, Pearlman E, Lewis D, Winner PK, Rothner D, Linder SL, Runken MC, Richard NE, Derosier FJ. Long-term evaluation of sumatriptan and naproxen sodium for the acute treatment of migraine in adolescents. Headache. 2011 Oct;51(9):1374-87. Epub 2011 Jul 28.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00488514 History of Changes
Other Study ID Numbers:	TXA107977
Study First Received:	June 18, 2007
Results First Received:	August 6, 2010
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration