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

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