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

Recruitment & Eligibility

Inclusion Criteria

Subject is male or female between the ages of 18 and 65, inclusive
Subject has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening
Subject has experienced between 4 and 10 migraine headaches per month (inclusive) over the past six months, with at least 24 hours separating attacks
Subject has less than 15 total headache days per month
Subject is able to differentiate migraine attacks from other headache types, if applicable
Subjects daily medications (for any indication) have remained at a stable dose for the 60 days preceding screening
Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator and mutually agreed upon with patient), if female of child-bearing potential
Subjects currently taking a single agent for the prevention of migraine must be on a stable dose (unchanged for 2 months) prior to study entry
Subject has negative urine pregnancy test prior to study entry, if female of child-bearing potential
Subject is able to understand and comply with all study requirements
Subject provides written informed consent prior to any screening procedures being conducted

EXCLUSION CRITERIA:

Subjects with onset of migraine after 50 years of age
Subjects who have been previously treated or are currently being treated with duloxetine
Subjects who have failed greater than 3 adequate trials of other medications the prevention of migraine, as determined by investigator
Subjects who have a known hypersensitivity to duloxetine or any of the inactive ingredients
Subject has taken any medication which has been shown to be effective for migraine prophylaxis, on a daily basis within the 4 weeks prior to screening or at any time during participation in the study, for any indication.
Subjects with a history of significant drug or alcohol abuse within the past year
Subjects with major depressive disorder or who have had a suicidal ideation in the 3 months prior to screening or have a history of attempted suicide
Subjects who have a Beck Depression Inventory score of > 18 at screening
Subjects who have > 0 on question number 9 of Beck Depression Inventory (Suicidal Thoughts or Wishes question)
Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
Subjects with a current or history of a hepatic or renal disorder
Subjects with uncontrolled narrow angle glaucoma
Subjects who have experienced significant side effects from two different SSRI and/or SNRI therapies, as determined by investigator
Subjects with uncontrolled restless legs syndrome, as determined by investigator

Exclusion Criteria

Not provided

Study & Design

Arm && Interventions

Group	Intervention	Description
Duloxetine	duloxetine	Duloxetine 120mg daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Frequency of Migraine Days During the Last 28 Day Interval of the Treatment Period as Compared to the 28 Day Baseline Period.	Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).	Change in frequency of migraine days from day -28 to day 0 (28 days) was compared to frequency of migraine days from day 56-84 (final 28 days of study).

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility