CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
duloxetinedrug
Likely dose
duloxetine 120 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/NCT00443352
NCT00443352Phase 4Completed
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A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine

Thomas Jefferson University·interventional·Posted Mar 6, 2007·Updated May 26, 2014

In Brief

A Phase 4 clinical trial evaluating duloxetine for Migraine. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This is a single-center, open-label, pilot trial to collect and evaluate data on the safety and efficacy of duloxetine in the preventive treatment of subjects experiencing episodic migraine headaches. Following a 28-day baseline period, qualifying subjects will be entered into an 84-day treatment period. Subjects will be titrated over the first four weeks to a dose of 120mg or their maximally tolerated dose (MTD). The dose adjustments will be based on individual subject response and/or subject's tolerability. Subjects will maintain a daily diary capturing detailed information on migraine headache days.

Study Details

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

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 6, 2007
Enrollment StartAug 1, 2007
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 19.3 years ago

Interventions

duloxetinedrug

Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)