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Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents

NCT00488514•GlaxoSmithKline

View on ClinicalTrials.gov

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

Age

12 - 17 years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (77)

GSK Investigational Site

Gilbert, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Chico, California, United States

GSK Investigational Site

Fair Oaks, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Fullerton, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Irvine, California, United States

Key Dates

Start Date

July 13, 2007

Primary Completion Date

August 1, 2009

Completion Date

August 20, 2009

Last Updated

May 18, 2017

Enrollment

656

ACTUAL participants

Conditions

Migraine Disorders

Interventions

Combination Tablet of Treximet (sumatriptan/naproxen sodium)

DRUG

Mind Body Balance for Pediatric Migraine

NCT04715685

HeadacheHeadache Disorders+6 more

View study

RECRUITING

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

NCT05570149

Migraine Disorders

View study

RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Mind Body Balance for Pediatric Migraine

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