drugset / Trial / NCT00443352

A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache

NCT00443352

Phase 4 Completed 27 enrolled Thomas Jefferson University
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2007-08
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 120 mg

Indications