Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack

Inclusion Criteria:

• Male and female subjects between the ages of 18 and 65, inclusive
• Subject diagnosed with episodic migraine, with or without aura according to ICHD-2criteria for at least one-year prior to screening
• Subject experiences between 2-10 migraine attacks per month (during the previous 6months) with no more than 15 days of headache per month.
• Subject is using or agrees to use for the duration of participation a medicallyacceptable form of contraception (as determined by investigator), if female and ofchild-bearing potential
• Subject is able to come for 4 hour in-clinic treatment of an acute migraine attack
• Subjects are able to understand and comply with all study procedures.
• Subject provides written informed consent prior to any screening procedures beingconducted
• If subject is on an allowable migraine preventive medication, the dose has been stablefor at least 4 weeks prior to screening and the dose will remain stable throughoutstudy participation.

Exclusion Criteria:

• Unable to make a reliable self-report of pain intensity to pain relief
• Use of analgesic or opioid within 24 hours of onset of headache to be treated withstudy medication. (If subject has an eligible headache and has taken a triptan or DHEwithin 24 hours, but greater than 2 hours before study drug dosing, they can betreated with study medication.)
• Patients taking the following medications on a regular basis: warfarin, lithium,ACE-inhibitors, loop diuretics, thiazide diuretics, ARBs, and methotrexate.
• Patients with active, clinically significant anemia
• Patients with a history or evidence of asthma
• Patients with a history heart failure
• Subjects with severely impaired hepatic or renal function, as determined by theinvestigator
• Patients with a history of allergy or hypersensitivity to any component of IVIb,aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
• Pregnant or nursing women
• Patients who have a history of congenital bleeding diathesis (e.g., hemophilia) or anyactive clinically significant bleeding, or have underlying platelet dysfunctionincluding (but not limited to) idiopathic thrombocytopenic purpura, disseminatedintravascular coagulation, or congenital platelet dysfunction
• Patients who have GI bleeding that required medical intervention within the previous 6weeks (unless definitive surgery has been performed.)
• Patients who have a platelet count less than 100,000, as determined within the 28 daysprior to treatment
• Pre-existing or current dependence on opioids.
• Subjects who have participated in an investigational drug trial in the 30 days priorto the screening visit
• Subjects with uncontrolled hypertension