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Sponsors and Collaborators: |
Thomas Jefferson University UCB |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00203216 |
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.
Condition | Intervention |
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Migraine |
Drug: levetiracetam Procedure: Transcranial Magnetic Stimulation |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Single-Center, Open-Label Trial Examining the Efficacy and Safety of Levetiracetam for the Prophylactic Treatment of Migraine, With or Without Aura |
Estimated Enrollment: | 45 |
Study Start Date: | September 2002 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Jefferson Headache Center | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | William B Young, MD | Thomas Jefferson University, Jefferson Headache Center |
Study ID Numbers: | WBY/LEV01, 080-19000-H80001 |
Study First Received: | September 13, 2005 |
Last Updated: | May 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00203216 |
Health Authority: | United States: Food and Drug Administration |
Migraine Disorders Headache Central Nervous System Diseases Etiracetam |
Headache Disorders, Primary Brain Diseases Headache Disorders |
Nootropic Agents Therapeutic Uses Nervous System Diseases |
Central Nervous System Agents Pharmacologic Actions Anticonvulsants |