Preventive Treatment of Episodic and Chronic Migraine

Patients with episodic migraine with and/or without aura and chronic migraine will be
treated with 100 or 200 mg of milnacipran for a total of 4 months including a one month
titration phase and a 3 month maintenance phase. Baseline (pre-treatment) and
end-of-maintenance phase headache frequencies will be recorded. There is no placebo
treatment in this study. In addition to headache frequencies, other parameters being
measured include safety and tolerability.

Inclusion Criteria:

- Migraine with or without aura or chronic migraine.

- Subject age 18 to 70.

- At least 2 migraine attacks per month.

- Willing ang able to give written informed consent.

- Willing and able to complete the entire course of the study and to comply with study
instructions.

- Willing to taper and discontinue their current preventive medications.

Exclusion Criteria:

- Subject is pregnant, lactating or planning a pregnancy in the next year.

- Subject is female of child-bearing potential and not taking adequate forms of birth
control.

- Significant medical or psychiatric disease or abnormal laboratory data that would
preclude entry into this study.

- Previous failure of four or more adequate trials of preventive medication.

- Currently on any form of antidepressant for depression and not able to discontinue.

- Currently demonstrating medication overuse headache.

- Currently has uncontrolled narrow angle glaucoma.

- Currently taking monoamine oxidase inhibitors.

- Subject has a history of seizures.

- Participation in an investigational drug study within the last 30 days or 5
half-lives, whichever is longer.