At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 656 enrolled
Drug / intervention
Combination Tablet of Treximet (sumatriptan/naproxen sodium)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents
In Brief
A Phase 3 clinical trial evaluating Combination Tablet of Treximet (sumatriptan/naproxen sodium) for Migraine Disorders. Completed, enrolled 656 participants across 77 sites.
Detailed Summary
This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine Disorders
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2007
Enrollment StartJul 2007
Primary CompletionAug 2009
Study CompletionAug 2009
TodayJul 2026
First PostedJun 20, 2007
Enrollment StartJul 13, 2007
Primary CompletionAug 1, 2009
Study CompletionAug 20, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.0 years ago
Interventions
Combination Tablet of Treximet (sumatriptan/naproxen sodium)drug
Combination Tablet of Treximet(sumatriptan/naproxen sodium)