At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓IHS diagnosis of migraine with or without aura for ≥1 year before screening
- ✓4–10 migraine headaches per month over the past 6 months, with ≥48 hours between attacks
- ✓Able to differentiate migraine from other headache types
- ✕Migraine onset after age 50
- ✕>15 headache days per month
- ✕Prior levetiracetam treatment for migraine
- ✕Failed >3 adequate trials of other antiepileptic drugs for migraine prevention
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Center, Open-Label Trial Examining the Efficacy and Safety of Levetiracetam for the Prophylactic Treatment of Migraine, With or Without Aura
In Brief
A clinical study evaluating levetiracetam and Transcranial Magnetic Stimulation for Migraine. Completed, enrolled 31 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
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)