CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Treximet +1 moredrug
Likely dose
Treximet 85 mgfrom 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/NCT01138150
NCT01138150Phase 4Completed
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Ictal and Interictal Inflammatory Markers in Migraine

Johns Hopkins University·interventional·Posted Jun 7, 2010·Updated Oct 6, 2016

In Brief

A Phase 4 clinical trial evaluating Treximet and Placebo for Migraine. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate blood levels of several proteins that may be altered in the inflammation associated with migraine headaches. These blood levels will be evaluated in individuals during an acute migraine attack and compared to their levels when pain free. The investigators study hypothesis is that the pro inflammatory proteins in the blood will be greater than the levels of these proteins when evaluated during a pain free period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
CollaboratorsUniversity of Toledo Health Science Campus, The Cleveland Clinic

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2010
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.1 years ago

Interventions

Treximetdrug

One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.

Placebodrug

One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.