The study drug levetiracetam is FDA approved as an add-on medication in the treatment of partial onset seizures in adults with epilepsy. The trade name is Keppra®. This is an "open-label" trial, which means that all participating patients will receive active study drug. The Jefferson Headache Center has developed this clinical study to evaluate the safety and effectiveness of levetiracetam in preventing migraine headaches, with or without aura (visual disturbances). In addition, the study site will be performing a procedure called Transcranial Magnetic Stimulation (TMS). This procedure measures brain activity because it is thought that people with migraine experience periods of cortical hyperexcitability or over-activity in the brain. This information may help physicians in the future determine which preventive medications will work for which patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Daily dose of open label levatiracetam was 3000 mg. or maximally tolerated dose. (Maximum daily dose: 3000 mg. Minimum daily dose allowed for study participation:1000 mg)
Jefferson Headache Center
Philadelphia, Pennsylvania, United States
The Primary Outcome is Defined as Average Change in Frequency of Migraine Attacks Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.
Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals: * visit\_4 = first follow-up interval (0 to 28 days after starting study drug) * visit\_5 = second follow-up interval (28 to 56 days) * visit\_6 = third follow-up interval (56 to 84 days) * visit\_7 = fourth follow-up interval (84 to 126 days) The change in headache attacks post-treatment will be averaged in a multiple regression model, looking at the following: visit number, age, gender, BMI
Time frame: Compare frequency of migraine attacks in baseline period to the average of the change following these 28 day periods prior to: Visit 4 (day 0-28), visit 5 (day 28-56), visit 6 (day 576-84), visit 7 (day 84-126).
Change in Number of Migraine Days Over Each 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period
Number of migraine attacks will be measured at baseline (28 day period prior to start of study medication). The baseline number of attacks will be compared to that in the following 28 day intervals: * visit\_4 = first follow-up interval (0 to 28 days after starting study drug) * visit\_5 = second follow-up interval (28 to 56 days) * visit\_6 = third follow-up interval (56 to 84 days) * visit\_7 = fourth follow-up interval (84 to 126 days)
Time frame: Baseline period (day -28 to day 0) compared to the 28 day period prior to Visit 4-7.
Change in Average Severity if Migraine Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period
Time frame: Baseline period compared to 28 day interval prior to Visit 4-7.
Change in Use of Acute Agents Attacks Per Each Consecutive 4-week Interval of the Treatment Period as Compared to the 4-week Baseline Period.
Time frame: Baseline period compared to the 28 day period prior to each of the following visits: Visit 4-7.
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