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NCT00203216 · ClinicalTrials.gov registry record · NA
A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches
A NA study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT00203216: Completed NA study, sponsored by Thomas Jefferson University.
NCT00203216 is a NA study that has completed, run by Thomas Jefferson University. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00203216, a NA study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study 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.
Primary Outcome
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 av
Interventions
- DRUG levetiracetam
- PROCEDURE Transcranial Magnetic Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2002-09 |
| Est. Completion | 2005-09 |
| Phase | NA |
What the finished NCT00203216 record still lists
NCT00203216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which levetiracetam is the first listed.
NCT00203216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00203216 about?
NCT00203216 is a clinical study titled "A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches". 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 Cente...
What is the current status of trial NCT00203216?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2002-09. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00203216?
The interventions under investigation include: levetiracetam (DRUG), Transcranial Magnetic Stimulation (PROCEDURE).
Who is sponsoring clinical trial NCT00203216?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00203216's enrollment target sits among peer trials
31 1592nd of 2000 higher than 408 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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