Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443352
Status:
COMPLETED
Last Update Posted:
2014-05-26
First Post:
2007-03-05
Brief Title:
A Research Study Examining The Use Of Duloxetine In The Prevention Of Migraine Headache
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
A Single-Center Open Label Pilot Study Examining The Use Of Duloxetine In The Prevention Of Episodic Migraine
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor subjects 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 subjects 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 andor subjects tolerability Subjects will maintain a daily diary capturing detailed information on migraine headache days
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 andor subjects tolerability Subjects will maintain a daily diary capturing detailed information on migraine headache days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None