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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00488514
First received: June 18, 2007
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Migraine Disorders
Drug: Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With the Indicated Drug-related Adverse Events [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: >=2% participants recorded as having at least one occurrence of a reported drug-related AE.


Secondary Outcome Measures:
  • Number of Participants With Any Adverse Event Categorized by Severity [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded.

  • Number of Participants With Any Adverse Event Categorized Over Time [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; <=194 days) or the second six months of the study (months 6-12; =>194 days until end of study) was recorded.

  • Number of Participants With Any Adverse Event Categorized by Participant Age [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded.

  • Number of Participants With Any Adverse Event Categorized by Participant Race [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The number of participants with any adverse event was categorized by race. The category "Other" captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White.

  • Number of Participants With Any Adverse Event Categorized by Participant Gender [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The number of participants with adverse events by gender is recorded.

  • 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) ] [ Designated as safety issue: No ]
    The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded.

  • 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) ] [ Designated as safety issue: No ]
    The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively.

  • 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) ] [ Designated as safety issue: No ]
    A shift from "normal to low," for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), >13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, >13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), >13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), >13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL).

  • 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) ] [ Designated as safety issue: No ]
    A shift from "normal to low," for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490.

  • Mean Height for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • Mean Weight for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
    BMI = (Weight in kilograms)/(height in centimeters/100)^2

  • Mean Blood Pressure for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
    At each visit, a participant's blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure.

  • Mean Heart Rate for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
    A sitting heart rate was measured once for each participant at each visit.

  • 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) ] [ Designated as safety issue: No ]
    The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator.

  • Number of Treated Migraine Attacks [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John's Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet.

  • 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) ] [ Designated as safety issue: No ]
    The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 24 hours after the participant was dosed with the Combination Tablet.

  • 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) ] [ Designated as safety issue: No ]
    The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.

  • 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) ] [ Designated as safety issue: No ]
    The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet.

  • Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet.

  • Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized.

  • Number of Migraine Attacks Rated With the Indicated Pain Severity [ Time Frame: Baseline through End of Study (up to Month 12) ] [ Designated as safety issue: No ]
    The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe.

  • 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) ] [ Designated as safety issue: No ]
    The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound.

  • 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 ] [ Designated as safety issue: No ]
    The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status.

  • 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 ] [ Designated as safety issue: No ]
    The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from "very satisfied" (1) to "very dissatisfied" (7).

  • 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 ] [ Designated as safety issue: No ]
    The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from "very satisfied" (1) to "very dissatisfied" (7).


Enrollment: 656
Study Start Date: July 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Drug
Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Drug: Combination Tablet of Treximet (sumatriptan/naproxen sodium)
Combination Tablet of Treximet(sumatriptan/naproxen sodium)
Other Name: Combination Product (sumatriptan succinate / naproxen sodium)

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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488514

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Gilbert, Arizona, United States, 85234
GSK Investigational Site
Phoenix, Arizona, United States, 85014
United States, Arkansas
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site
Chico, California, United States, 95926
GSK Investigational Site
Fair Oaks, California, United States, 95628
GSK Investigational Site
Fresno, California, United States, 93720
GSK Investigational Site
Fullerton, California, United States, 92835
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Irvine, California, United States, 92618
GSK Investigational Site
La Jolla, California, United States, 92037
GSK Investigational Site
Newport Beach, California, United States, 92660
GSK Investigational Site
Northridge, California, United States, 91325
GSK Investigational Site
Redondo Beach, California, United States, 90277
GSK Investigational Site
Roseville, California, United States, 95678
GSK Investigational Site
Sacramento, California, United States, 92585
GSK Investigational Site
San Francisco, California, United States, 94109
GSK Investigational Site
Santa Monica, California, United States, 90404
GSK Investigational Site
Walnut Creek, California, United States, 94596
United States, Colorado
GSK Investigational Site
Aurora, Colorado, United States, 80045
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
GSK Investigational Site
East Hartford, Connecticut, United States, 06118-3239
GSK Investigational Site
Fairfield, Connecticut, United States, 06824
United States, Florida
GSK Investigational Site
Loxahatchee, Florida, United States, 33470
GSK Investigational Site
Pensacola, Florida, United States, 32504
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Savannah, Georgia, United States, 31405
United States, Indiana
GSK Investigational Site
Anderson, Indiana, United States, 46011
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
GSK Investigational Site
Murray, Kentucky, United States, 42071
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48104
GSK Investigational Site
Kalamazoo, Michigan, United States, 49008
GSK Investigational Site
Paw Paw, Michigan, United States, 49079
GSK Investigational Site
Protage, Michigan, United States, 49024
GSK Investigational Site
Richland, Michigan, United States, 49083
United States, Minnesota
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68130
United States, Nevada
GSK Investigational Site
Henderson, Nevada, United States, 89014
United States, New Jersey
GSK Investigational Site
Ridgewood, New Jersey, United States, 7450
GSK Investigational Site
Vorhees, New Jersey, United States, 08043
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
GSK Investigational Site
Albany, New York, United States, 12206
GSK Investigational Site
Amherst, New York, United States, 14226
GSK Investigational Site
Endwell, New York, United States, 13760
GSK Investigational Site
Mount Vernon, New York, United States, 10550
GSK Investigational Site
New York, New York, United States, 10022
GSK Investigational Site
Plainview, New York, United States, 11803
GSK Investigational Site
Rochester, New York, United States, 14609
GSK Investigational Site
Rochester, New York, United States, 14642
GSK Investigational Site
Williamsville, New York, United States, 14221
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45229
GSK Investigational Site
Cleveland, Ohio, United States, 44195
GSK Investigational Site
Columbus, Ohio, United States, 43205
GSK Investigational Site
Westerville, Ohio, United States, 43081
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Medford, Oregon, United States, 97504-8456
GSK Investigational Site
Portland, Oregon, United States, 97210
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75230
GSK Investigational Site
Georgetown, Texas, United States, 78626
GSK Investigational Site
Nassau Bay, Texas, United States, 77058
GSK Investigational Site
Plano, Texas, United States, 79075
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22902
GSK Investigational Site
Norfolk, Virginia, United States, 23510
United States, Washington
GSK Investigational Site
Bremerton, Washington, United States, 98310
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
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: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Long-term Safety
Migraine
Adolescent Migraine Headache
sumatriptan succinate
naproxen sodium

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Naproxen
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 31, 2014