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Clinical Trials
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 patient’s choice whether
to enroll in a clinical trial.
A clinical trial, which typically has three stages,
or phases, gauges a drug’s 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.
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