NCT00443352

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

A Single-Center, Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pharmacologic therapy of migraine headaches can be divided into two types: acute treatment and prophylactic treatment. Acute headache medication is intended to relieve the pain and disability of an acute attack and stop its progression. Prophylactic (preventive) headache therapy is generally given daily, even in the absence of headache, to reduce the frequency and perhaps the severity of anticipated attacks. Subjects who experience recurring migraine attacks which significantly interfere with the subject's daily routine despite acute treatment, may warrant chronic prophylactic treatment. Duloxetine may be an important treatment option for millions of unsuccessfully treated migraine patients and therefore warrants further study. Considering this, we propose 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 with episodic migraine headaches. The results of this pilot trial will provide preliminary insight into the clinical role duloxetine may play in the treatment of headache, as well as provide a basis for future well-controlled trials of this medication. 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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	duloxetine	Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)

Timeline

• Start date: 2007-08-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2007-03-06
• Last updated: 2014-05-26
• Results posted: 2014-05-26

Locations

1 site across 1 country: United States