A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches

Inclusion criteria

• Patient is male or female between the ages of 18 and 65
• Patient has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening
• Patient has experienced between 4 and 10 migraine headaches per month over the past six months, with at least 48 hours separating attacks
• Patient is able to differentiate migraine attacks from other headache types, if applicable
• Patient is not currently and has not in the 4 weeks preceding screening received prophylactic treatment for the indication of migraine
• Patients daily medications have remained at a stable dose for the 4 weeks preceding screening
• Patient is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
• Patient has negative urine pregnancy test prior to study entry, if female of child-bearing potential
• Patient is able to understand and comply with all study requirements
• Patient provides written informed consent prior to any screening procedures being conducted

Exclusion criteria

• Women who are pregnant or lactating
• Patients with onset of migraine after 50 years of age
• Patients who experience > 15 headache days per month
• Patients who have been previously treated or are currently being treated with levitiracetam
• Patients who have failed greater than 3 adequate trials of other antiepileptic drugs for the prevention of migraine.
• Patients who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
• Patients with an abnormal ECG that, in the investigators opinion, would expose them to increased risk of adverse events or interfere with study drug and/or analysis of efficacy/tolerability
• Patients who take medication for acute treatment greater than 10 days per month over the past three months.
• Patients who are allergic to or have shown hypersensitivity to compounds similar to levetiracetam
• Patients with a history of significant drug or alcohol abuse within the past year
• Patients who have had a suicidal ideation in the 3 months prior to screening or has a history of attempted suicide
• Patients who currently have or have a history of significantly impaired renal function
• Patients who have participated in an investigational drug trial in the 30 days prior to the screening visit
• Patients who have a Beck Depression Inventory score of > 18 at screening
• Patients who have > 0 on question number 9 of Beck Depression Inventory (Suicidal Thoughts or Wishes question)
• Patients who have a defibrillator or pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull (e.g. a shrapnel wound).