Open Label Safety Study in Acute Treatment of Migraine

Inclusion Criteria:

- Subjects with 2-8 moderate to severe migraines/month

- Age of onset of migraines prior to 50 years of age

- Migraine attacks, on average, lasting 4-72 hours if untreated

- Ability to distinguish migraine attacks from tension/cluster headaches

- Patients with contraindications for use of triptans may be included provided they meet
all other study entry criteria

Exclusion Criteria:

- History of basilar migraine or hemiplegic migraine

- History of HIV disease

- History with current evidence of uncontrolled, unstable or recently diagnosed
cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and
cerebral ischemia.

- Uncontrolled hypertension or uncontrolled diabetes (however, patients can be included
who have stable hypertension and /or diabetes for 3 months prior to screening

- History of gastric or small intestinal surgery or has a disease that causes
malabsorption

- BMI ≥ 30

- HbA1c ≥ 6.5%