Last updated: 11/04/2018 13:02:12
Long-Term Safety of Treximet (sumatriptan/naproxen sodium) for Migraine in Adolescents
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents
Trial description: This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with the indicated drug-related adverse events
Timeframe: Baseline through End of Study (up to Month 12)
Secondary outcomes:
Number of participants with any adverse event categorized by severity
Timeframe: Baseline through End of Study (up to Month 12)
Number of participants with any adverse event categorized over time
Timeframe: Baseline through End of Study (up to Month 12)
Number of participants with any adverse event categorized by participant age
Timeframe: Baseline through End of Study (up to Month 12)
Number of participants with any adverse event categorized by participant race
Timeframe: Baseline through End of Study (up to Month 12)
Number of participants with any adverse event categorized by participant gender
Timeframe: Baseline through End of Study (up to Month 12)
Number of participants with any adverse event that occurred within 3 or 5 days of the first dose of the Combination Tablet
Timeframe: Baseline through End of Study (up to Month 12)
Number of tablets taken, after which at least one adverse event occurred within 3 or 5 days of dosing with that Combination Tablet
Timeframe: Baseline through End of Study (up to Month 12)
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
Timeframe: Baseline through End of Study (up to Month 12)
Number of participants with hematocrit and hemoglobin values of interest that shifted from normal at baseline to abnormal at the end of study visit
Timeframe: Baseline through End of Study (up to Month 12)
Mean height for all study participants at the indicated time points
Timeframe: Screening and Months 3, 6, 9, and 12
Mean weight for all study participants at the indicated time points
Timeframe: Screening and Months 3, 6, 9, and 12
Mean body mass index (BMI) for all study participants at the indicated time points
Timeframe: Screening and Months 3, 6, 9, and 12
Mean blood pressure for all study participants at the indicated time points
Timeframe: Screening and Months 3, 6, 9, and 12
Mean heart rate for all study participants at the indicated time points
Timeframe: Screening and Months 3, 6, 9, and 12
Number of participants with abnormal electrocardiogram findings at Screening and at the Final Visit as assessed by the Investigator
Timeframe: Screening and Final Visit (up to Month 12)
Number of treated migraine attacks
Timeframe: Baseline through End of Study (up to Month 12)
Number of Treated Attacks Classified as Migraine Pain-Free (MPF) within 24 Hours of dosing with the Combination Tablet
Timeframe: Baseline through End of Study (up to Month 12)
Number of Treated Attacks Classified as Migraine Pain-Free (MPF) within 4 Hours of dosing with a Combination tablet
Timeframe: Baseline through End of Study (up to Month 12)
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
Timeframe: Baseline through End of Study (up to Month 12)
Average number of headaches, migraine attacks, and treated migraine attacks per month
Timeframe: Baseline through End of Study (up to Month 12)
Number of total migraines headaches and migraines treated with the combination tablet
Timeframe: Baseline through End of Study (up to Month 12)
Number of migraine attacks rated with the indicated pain severity
Timeframe: Baseline through End of Study (up to Month 12)
Number of treated migraine attacks with photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting
Timeframe: Baseline through End of Study (up to Month 12)
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
Timeframe: Baseline and Months 3, 6, 9, and 12
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
Timeframe: Screening
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
Timeframe: End of Study/Month 12
Interventions:
Drug: Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Enrollment:
656
Observational study model:
Not applicable
Primary completion date:
2009-20-08
Time perspective:
Not applicable
Clinical publications:
McDonald SA, Hershey AD, Pearlman EM, Lewis D, Winner PK, Rothner DA, Linder SL, Runken MC, Richard NE, Derosier FJ. Long-term Evaluation of a Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents. [Headache]. 2011;
Medical condition
Migraine Disorders
Product
naproxen, sumatriptan, sumatriptan/naproxen
Collaborators
Not applicable
Study date(s)
July 2007 to August 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 17 years
Accepts healthy volunteers
No
- Subject is between 12 and 17 years old at the Screening visit.
- If subject is female, she must have a negative urine pregnancy test at screening, does not plan to become pregnant during the course of the study and agrees to use an acceptable method of birth control (i.e., a method with a failure rate <1% or abstinence) if she is/becomes sexually active.
- Subject is < 75 pounds (33.3kg).
- Subject has ≥15 headache days per month in total, retinal (ICHD-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches.
Inclusion and exclusion criteria
Inclusion criteria:
- Subject is between 12 and 17 years old at the Screening visit.
- If subject is female, she must have a negative urine pregnancy test at screening, does not plan to become pregnant during the course of the study and agrees to use an acceptable method of birth control (i.e., a method with a failure rate <1% or abstinence) if she is/becomes sexually active.
- Subject has migraine with or without aura (2004 ICHD-II criteria).
- Subject has history suggestive of typical migraine attacks with duration of about 2 or more hours (untreated, or unsuccessfully treated).
- Subject has at least 2, but not more than 8, migraine attacks per month in each of the 2 months prior to the Screening visit.
- Subject has at least a 6-month history of moderate to severe migraine attacks, sufficient to establish a definitive diagnosis of migraine.
- Subject is able to distinguish migraine from other headaches (e.g., tension-type headaches).
- Subject and subject’s parent or legal guardian are willing and able to provide informed consent prior to entry into this treatment phase of the study.
- Subject and subject’s parent or legal guardian are able to read and write English or Spanish.
- Subject is able to understand and complete the electronic device to report treatment information.
Exclusion criteria:
- Subject is < 75 pounds (33.3kg).
- Subject has ≥15 headache days per month in total, retinal (ICHD-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches.
- Subject, in the investigator’s opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (See Appendix 1, section 11.1).
- Subject has uncontrolled hypertension (See Appendix 2, section 11.2) 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 Raynaud’s Syndrome, 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 is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; 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 his/her 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 2 weeks prior to screening through 2 weeks post final study treatment.
- Subject 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 or GI ulceration or perforation in the past six months, gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease.
- Subject tests positive for illicit substances on toxicology screen, or has evidence of alcohol or substance abuse within the last year, or any concurrent medical or psychiatric condition which, in the investigator’s judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.
- Subject has participated in an investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.
Trial location(s)
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
Status
Study Complete
Location
GSK Investigational Site
Plainview, New York, United States, 11803
Status
Study Complete
Location
GSK Investigational Site
Protage, Michigan, United States, 49024
Status
Study Complete
Location
GSK Investigational Site
Bremerton, Washington, United States, 98310
Status
Study Complete
Location
GSK Investigational Site
Fairfield, Connecticut, United States, 06824
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Medford, Oregon, United States, 97504-8456
Status
Study Complete
Location
GSK Investigational Site
Ridgewood, New Jersey, United States, 7450
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sacramento, California, United States, 92585
Status
Study Complete
Location
GSK Investigational Site
Endwell, New York, United States, 13760
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31405
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Murray, Kentucky, United States, 42071
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Loxahatchee, Florida, United States, 33470
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Vorhees, New Jersey, United States, 08043
Status
Study Complete
Location
GSK Investigational Site
Aurora, Colorado, United States, 80045
Status
Study Complete
Location
GSK Investigational Site
Mount Vernon, New York, United States, 10550
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92037
Status
Study Complete
Location
GSK Investigational Site
Plano, Texas, United States, 79075
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22902
Status
Study Complete
Location
GSK Investigational Site
New Brunswick, New Jersey, United States, 08901
Status
Study Complete
Location
GSK Investigational Site
Williamsville, New York, United States, 14221
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Northridge, California, United States, 91325
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85014
Status
Study Complete
Location
GSK Investigational Site
Redondo Beach, California, United States, 90277
Status
Study Complete
Location
GSK Investigational Site
Irvine, California, United States, 92618
Status
Study Complete
Location
GSK Investigational Site
Pensacola, Florida, United States, 32504
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48104
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10022
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
Location
GSK Investigational Site
East Hartford, Connecticut, United States, 06118-3239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
Status
Study Complete
Location
GSK Investigational Site
Chico, California, United States, 95926
Status
Study Complete
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Richland, Michigan, United States, 49083
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12206
Status
Study Complete
Location
GSK Investigational Site
Westerville, Ohio, United States, 43081
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94109
Status
Study Complete
Location
GSK Investigational Site
Fair Oaks, California, United States, 95628
Status
Study Complete
Location
GSK Investigational Site
Henderson, Nevada, United States, 89014
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95678
Status
Study Complete
Location
GSK Investigational Site
Amherst, New York, United States, 14226
Status
Study Complete
Location
GSK Investigational Site
Newport Beach, California, United States, 92660
Status
Study Complete
Location
GSK Investigational Site
Georgetown, Texas, United States, 78626
Status
Study Complete
Location
GSK Investigational Site
Naples, Florida, United States, 34102
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Anderson, Indiana, United States, 46011
Status
Study Complete
Location
GSK Investigational Site
Paw Paw, Michigan, United States, 49079
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14642
Status
Study Complete
Location
GSK Investigational Site
Nassau Bay, Texas, United States, 77058
Status
Study Complete
Location
GSK Investigational Site
Gilbert, Arizona, United States, 85234
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23510
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49008
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-20-08
Actual study completion date
2009-20-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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