Migraine Study in Adolescent Patients
TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents
1 other identifier
interventional
589
1 country
79
Brief Summary
This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2008
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
May 9, 2011
CompletedJanuary 18, 2017
November 1, 2016
1.4 years
February 12, 2009
January 22, 2011
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Were Pain Free at 2 Hours Post-dose
Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.
2 hours after single dose of double-blind treatment (Randomization through Week 13)
Secondary Outcomes (10)
Number of Participants Sustained Pain-free From 2-24 Hours
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Photophobia-free at 2 Hours Post-dose
2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Phonophobia-free at 2 Hours Post-dose
2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Pain-free at 1 Hour Post-dose
1 hour after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Sustained Photophobia-free From 2-24 Hours
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
- +5 more secondary outcomes
Other Outcomes (6)
Mean Age of Participants at Baseline Categorized by Age Group
Baseline
Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline
Baseline
Number of Female and Male Participants Categorized by Age Group
Baseline
- +3 more other outcomes
Study Arms (4)
Sumatriptan and Naproxen 1
EXPERIMENTALSumatriptan succinate and naproxen sodium combination 10mg/60mg
Sumatriptan and Naproxen 2
EXPERIMENTALSumatriptan succinate and naproxen sodium combination 30mg/180mg
Sumatriptan and Naproxen 3
EXPERIMENTALSumatriptan succinate and naproxen sodium combination 85mg/500mg
Placebo
PLACEBO COMPARATORPlacebo to match
Interventions
Sumatriptan succinate and naproxen sodium
Eligibility Criteria
You may qualify if:
- Subject is \>/=12 years of age and \</=17 years of age at the Screening Visit.
- Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least two, but no more than eight attacks per month, for the six months prior to the Screening Visit is required. Attacks should last a minimum of three hours and be associated with moderate-to-severe headache pain.
- Subject is able to distinguish migraine from other headaches (i.e., tension-type headaches).
- Male or female subjects. Female subjects are eligible for participation in the study if they are:
- Females of non-childbearing potential; or
- Females of childbearing potential, and who have a negative urine pregnancy test at screening, and agree to use one of the GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy
- Any subject taking oral contraceptives at enrollment must be on a stable regimen for at least 2 months prior to screening.
- Subject and subject's parent or legal guardian are able to read and write English or Spanish.
- Subject is able to read, comprehend, and complete subject diaries.
- Subject's parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study.
- Subject is willing and able to provide Informed Assent prior to entry into the study (if required).
You may not qualify if:
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Subject is \< 74 pounds (33.3 kg).
- Subject has ≥15 headache days per month in total (migraine, probable migraine, or tension-type), retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), or hemiplegic migraine (ICHD-II 1.2.4), or secondary headaches.
- Subject, in the investigator's opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.
- Subject has uncontrolled hypertension at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
- Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
- Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease, or signs/symptoms consistent with any of the above.
- Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
- Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
- Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID, or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma.
- Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
- Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
- Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the two weeks prior to screening through two weeks post treatment.
- Subject has a history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.
- Subject has evidence or history of any gastrointestinal surgery, GI ulceration, or perforation in the past six months, gastrointestinal bleeding in the past year, or evidence or history of inflammatory bowel disease.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (79)
GSK Investigational Site
Gilbert, Arizona, 85234, United States
GSK Investigational Site
Litchfield Park, Arizona, 85340, United States
GSK Investigational Site
Phoenix, Arizona, 85013, United States
GSK Investigational Site
Phoenix, Arizona, 85014, United States
GSK Investigational Site
Phoenix, Arizona, 85016, United States
GSK Investigational Site
Conway, Arkansas, 72034, United States
GSK Investigational Site
Little Rock, Arkansas, 72202, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Chico, California, 95926, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Fullteron, California, 92835, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Newport Beach, California, 92660, United States
GSK Investigational Site
Roseville, California, 95678, United States
GSK Investigational Site
Sacramento, California, 95815, United States
GSK Investigational Site
Sacramento, California, 95816, United States
GSK Investigational Site
San Francisco, California, 94109, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Fairfield, Connecticut, 06824, United States
GSK Investigational Site
Gainesville, Florida, 32607, United States
GSK Investigational Site
Hialeah, Florida, 33010, United States
GSK Investigational Site
Miami, Florida, 33155-3009, United States
GSK Investigational Site
Pensacola, Florida, 32504, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Savannah, Georgia, 31405, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Chicago, Illinois, 60642, United States
GSK Investigational Site
Oak Lawn, Illinois, 60453, United States
GSK Investigational Site
Park Ridge, Illinois, 60068, United States
GSK Investigational Site
Anderson, Indiana, 46011, United States
GSK Investigational Site
Terre Haute, Indiana, 47802, United States
GSK Investigational Site
Kansas City, Kansas, 66160, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Lexington, Kentucky, 40509, United States
GSK Investigational Site
Pikesville, Maryland, 21208, United States
GSK Investigational Site
Worcester, Massachusetts, 01605, United States
GSK Investigational Site
Ann Arbor, Michigan, 48104, United States
GSK Investigational Site
Plymouth, Minnesota, 55441, United States
GSK Investigational Site
Springfield, Missouri, 65807, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
Henderson, Nevada, 89014, United States
GSK Investigational Site
Vorhees, New Jersey, 08043, United States
GSK Investigational Site
Willingboro, New Jersey, 08046, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Amherst, New York, 14226, United States
GSK Investigational Site
Mineola, New York, 11501, United States
GSK Investigational Site
Mount Vernon, New York, 10550, United States
GSK Investigational Site
Schenectady, New York, 12308, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Cincinnati, Ohio, 45229, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Cleveland, Ohio, 44195, United States
GSK Investigational Site
West Chester, Ohio, 45069, United States
GSK Investigational Site
Westerville, Ohio, 43081, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Eugene, Oregon, 97401, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Salem, Oregon, 97301, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19139, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Clarksville, Tennessee, 37043, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Houston, Texas, 77030-2303, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
GSK Investigational Site
Charlottesville, Virginia, 22902, United States
GSK Investigational Site
Norfolk, Virginia, 23510, United States
GSK Investigational Site
Seattle, Washington, 98195-6097, United States
GSK Investigational Site
Vancouver, Washington, 98686, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Madison, Wisconsin, 53715, United States
GSK Investigational Site
Middleton, Wisconsin, 53562-2215, United States
Related Publications (2)
Brandes JL, Kudrow D, Stark SR, O'Carroll CP, Adelman JU, O'Donnell FJ, Alexander WJ, Spruill SE, Barrett PS, Lener SE. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007 Apr 4;297(13):1443-54. doi: 10.1001/jama.297.13.1443.
PMID: 17405970BACKGROUNDDerosier FJ, Lewis D, Hershey AD, Winner PK, Pearlman E, Rothner AD, Linder SL, Goodman DK, Jimenez TB, Granberry WK, Runken MC. Randomized trial of sumatriptan and naproxen sodium combination in adolescent migraine. Pediatrics. 2012 Jun;129(6):e1411-20. doi: 10.1542/peds.2011-2455. Epub 2012 May 14.
PMID: 22585767DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
December 1, 2008
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
January 18, 2017
Results First Posted
May 9, 2011
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.