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
Study complete
Study complete
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:
Enrollment:
656
Primary completion date:
2009-20-08
Observational study model:
Not applicable
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
Showing 1 - 6 of 77 Results
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
Study complete
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
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website