CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Sumatriptan/Naproxen Sodium +1 moredrug
Likely dose
Sumatriptan/Naproxen Sodium 85mgfrom 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.

Search/NCT01300546
NCT01300546Phase 4Completed
CompareCT.gov

TreximetTM in the Prevention and Modification of Disease Progression in Migraine

Cady, Roger, M.D.·interventional·Posted Feb 21, 2011·Updated May 21, 2013

In Brief

A Phase 4 clinical trial evaluating Sumatriptan/Naproxen Sodium and Naproxen Sodium for Migraine. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

This study is being conducted to evaluate the hypothesis that use of pharmacological and non-pharmacological interventions may allow subjects at high risk for chronic migraine to avoid or reverse the transformation of episodic migraine to chronic migraine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2011
Enrollment StartDec 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.4 years ago

Interventions

Sumatriptan/Naproxen Sodiumdrug

Each tablet of Treximet for oral administration contains Sumatriptan 85mg / Naproxen Sodium 500mg. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.

Naproxen Sodiumdrug

Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.