Penn State Hershey to participate in anti-seizure drug study

Penn State Milton S. Hershey Medical Center’s Department of Emergency Medicine is participating in a clinical research study called RAMPART, Rapid Anticonvulsant Medications Prior to Arrival Trial. This national trial is studying whether use of one FDA-approved seizure drug administered by EMS personnel as a shot is as effective as one administered intravenously.

Two similar medicines -- midazolam and lorazepam -- will be used. Lorazepam is commonly given intravenously and midazolam is commonly given as a shot in the muscles. Both already are used by paramedics in the field and by doctors in the hospital to stop seizures.

Patients in this study are randomized as to which medicine they will receive. Persons who receive a midazolam shot in the muscle also will receive placebo (saline) by an IV. Persons who receive lorazepam by an IV will also receive a placebo (saline) shot in the muscle. The person will never receive both doses of medication or two doses of placebo. This way no one knows which medication a patient is getting, but every patient will receive seizure medication treatment. If the seizure does not stop after 10 minutes following study medication administration, EMS will follow their normal procedure and may give more medication to the patient.

Since unconscious emergency patients, in this case a patient having a seizure, cannot say whether they do or do not want to participate in a research study, they cannot provide or refuse to give informed consent (permission). The Food and Drug Administration (FDA) developed federal regulations (21 CFR 50.24) that allow patients to be treated as part of research studies using an exception from informed consent for emergency research. Because participants in an EFIC study cannot choose to participate, investigators are required to consult the community to determine public opinion on the study prior to enrolling any patients.

Residents who do not want to participate may visit http://www.pennstatehershey.org/emergencymedicine or call 717-531-1707 option 5 for directions on how opt out, which will alert EMS of their wish not to be enrolled. Pregnant women and children less than 13 kilograms (29 pounds) are not eligible for this study. Residents of communities served by the LifeLion EMS are eligible to participate in the study.

Use of the EFIC provision in RAMPART is granted by the Institutional Review Board (IRB) responsible for the initial and continuing review and approval of the research study. The IRB requires that the Medical Center team present study information at public meetings and in other forums, and collect public comment about the study. A public meeting will be held at the University Conference Center on Dec. 23, 2009, starting at 9 a.m.. For meeting details, call 717-531-1707 option 5.

The principal investigator for this study is Christopher Vates, M.D. The IRB and the Human Subjects Protection Office, located at Penn State Hershey, can be reached by calling 717-531-5687.

 

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Last Updated December 16, 2009