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NRTX-1001 for the Treatment of Drug-resistant Bilateral Temporal Lobe Focal Seizures

UCI Specialty Area: Neurology
Principal Investigator: Mona Sazgar
Official Title: A Study of Inhibitory Interneurons (NRTX-1001) for the Treatment of Drug-resistant Bilateral Temporal Lobe Focal Seizures
A Study On:
Epilepsy

Study Description

This study is designed to obtain open-label feasibility, safety, and seizure frequency data in patients with drug-resistant bilateral mesial temporal lobe epilepsy (MTLE), with or without chronic indwelling intracranial electrodes. This is an open-label study of the bilateral administration of NRTX-1001, with the primary endpoint to evaluate safety and a secondary endpoint to evaluate seizure metrics during months 7-12 after NRTX-1001 administration. Up to ten subjects will receive 16x106 cells in each hippocampus.

Eligibility

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
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  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
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What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI