Open Label Safety Study in Acute Treatment of Migraine
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with 4-14 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
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