Clinical trial NCT00488514: Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Keywords: Long-term Safety
Migraine
Adolescent Migraine Headache
sumatriptan succinate
naproxen sodium
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 656
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.

Detailed description: This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents (aged 12 to 17 years) for the acute treatment of migraine.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With the Indicated Drug-related Adverse Events
timeFrame: Baseline through End of Study (up to Month 12)
Secondary outcomes:
measure: Number of Participants With Any Adverse Event Categorized by Severity
timeFrame: Baseline through End of Study (up to Month 12)
measure: Number of Participants With Any Adverse Event Categorized Over Time
timeFrame: Baseline through End of Study (up to Month 12)
measure: Number of Participants With Any Adverse Event Categorized by Participant Age
timeFrame: Baseline through End of Study (up to Month 12)
measure: Number of Participants With Any Adverse Event Categorized by Participant Race
timeFrame: Baseline through End of Study (up to Month 12)
measure: Number of Participants With Any Adverse Event Categorized by Participant Gender
timeFrame: Baseline through End of Study (up to Month 12)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Mean Height for All Study Participants at the Indicated Time Points
timeFrame: Screening and Months 3, 6, 9, and 12
measure: Mean Weight for All Study Participants at the Indicated Time Points
timeFrame: Screening and Months 3, 6, 9, and 12
measure: Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points
timeFrame: Screening and Months 3, 6, 9, and 12
measure: Mean Blood Pressure for All Study Participants at the Indicated Time Points
timeFrame: Screening and Months 3, 6, 9, and 12
measure: Mean Heart Rate for All Study Participants at the Indicated Time Points
timeFrame: Screening and Months 3, 6, 9, and 12
measure: 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)
measure: Number of Treated Migraine Attacks
timeFrame: Baseline through End of Study (up to Month 12)
measure: 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)
measure: 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)
measure: 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)
measure: Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month
timeFrame: Baseline through End of Study (up to Month 12)
measure: Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet
timeFrame: Baseline through End of Study (up to Month 12)
measure: Number of Migraine Attacks Rated With the Indicated Pain Severity
timeFrame: Baseline through End of Study (up to Month 12)
measure: 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)
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: GSK Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Chico
country: United States
facility: GSK Investigational Site
state: California
city: Fair Oaks
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Fullerton
country: United States
facility: GSK Investigational Site
state: California
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Irvine
country: United States
facility: GSK Investigational Site
state: California
city: La Jolla
country: United States
facility: GSK Investigational Site
state: California
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: Northridge
country: United States
facility: GSK Investigational Site
state: California
city: Redondo Beach
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: Sacramento
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Santa Monica
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Aurora
country: United States
facility: GSK Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: East Hartford
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Fairfield
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Loxahatchee
country: United States
facility: GSK Investigational Site
state: Florida
city: Naples
country: United States
facility: GSK Investigational Site
state: Florida
city: Pensacola
country: United States
facility: GSK Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Anderson
country: United States
facility: GSK Investigational Site
state: Indiana
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Murray
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Ann Arbor
country: United States
facility: GSK Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: GSK Investigational Site
state: Michigan
city: Paw Paw
country: United States
facility: GSK Investigational Site
state: Michigan
city: Protage
country: United States
facility: GSK Investigational Site
state: Michigan
city: Richland
country: United States
facility: GSK Investigational Site
state: Michigan
city: Plymouth
country: United States
facility: GSK Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: GSK Investigational Site
state: Nevada
city: New Brunswick
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Ridgewood
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Vorhees
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Amherst
country: United States
facility: GSK Investigational Site
state: New York
city: Endwell
country: United States
facility: GSK Investigational Site
state: New York
city: Mount Vernon
country: United States
facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Plainview
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Williamsville
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Westerville
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Greer
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Georgetown
country: United States
facility: GSK Investigational Site
state: Texas
city: Nassau Bay
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Bremerton
country: United States
facility: GSK Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1111/j.1526-4610.2011.01965.x. Epub 2011 Jul 28.