Clinical trials involve patients in the testing of new treatments and therapies and are part of the drug approval process in America. The University Comprehensive Epilepsy Center participates in several studies of AEDs, including newer drugs such as Topamax, Gabitril, and lamotrigine, but it is the patients choice whether to enroll in a clinical trial.
A clinical trial, which typically has three stages, or phases, gauges a drugs safety, effectiveness, dosage requirements, and side effects. A set of rules, or the protocol, is established for each trial.
The Center currently is enrolling patients in these studies:
1. Vagal Nerve Stimulation and Functional MRI. The Center is seeking patients over age 18 who have a vagal nerve stimulator. Participants undergo a total of three (3) Functional MRI studies during which the vagal nerve stimulator is turned off. A payment of $150 will be made upon completion of the third MRI. The investigators are Dr. David Marks and Dr. Andrew Kalnin; for more information, contact Martha Mulvey, R.N., at (973) 972-0570.
2. Topamax. Patients age 12 and older are needed for a study to ascertain how to adjust the dosage of Topamax when used with other antiepileptic drugs. The study lasts for 21 weeks, and the drug will be given to participants at no cost. Only routine blood work will be required. Patients who are pregnant may not participate in this study. The primary investigator is Dr. Jayoung Pak; for more information, contact Martha Mulvey, R.N., at (973) 972-0570.
3. Lamictal. A retrospective case study is being conducted of patients who have experienced rash or hypersensitivity after taking the antiepileptic drug Lamictal. Patients will have their blood drawn up to two times; no medications are required. The primary investigator is Dr. Jayoung Pak; for more information, contact Martha Mulvey, R.N., at (973) 972-0570.