Dose Ranging Study of a Drug for the Treatment of Acute Migraine

Intervention Model: Parallel Versus Comparator + Placebo

Inclusion Criteria:

- Patient with at least 1 year history of migraines (with or without aura) including the
following;

- Migraine attacks more than 1 year with age onset prior to 50 years of age;

- Migraine attacks, on average, last about 4 - 72 hours if untreated;

- No more than 8 attacks of moderate to severe intensity per month within last 3
months;

- Patient must be able to distinguish migraine attacks from tension/cluster attacks
and must have consistent migraine headaches of at least 2 migraine headaches
attacks of severe to moderate intensity in each of the last 3 months;

- Less than 15 days of headache (migraine or non migraine) per month in each of 3
months prior to screening;

- Male and female ≥ 18 years and ≤ age 65

- No clinically significant abnormality identified on the medical or laboratory
evaluation

Exclusion Criteria:

- Patient has a history of basilar migraine or hemiplegic migraine

- Patient does not receive migraine relief from triptan migraine treatment

- Medications that may alter the pH of the stomach (acid reducing agents), such as H-2
antagonists, Proton Pump inhibitors (PPI), antacids

- History of ergotamine or triptan intake greater than/equal 10 days per month on a
regular basis for greater than 3 months

- History of non-narcotic analgesic intake on greater then/equal 15 days per month for
greater than/equal 3 months