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NCT01793532 · ClinicalTrials.gov registry record

Study of [11C]DPA-713 for Temporal Lobe Epilepsy

A clinical trial of Epilepsy and Temporal Lobe, sponsored by National Institute of Mental Health (NIMH).

Completed
Registry status
38
Enrollment target
1
Study location

NCT01793532 is a study of Epilepsy and Temporal Lobe that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 38 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01793532, a study of Epilepsy and Temporal Lobe, has completed, sponsored by National Institute of Mental Health (NIMH).

COMPLETED
Registry status
38 participants
Enrollment target
1
Study location

Study Summary

Background: \- Some people with epilepsy have an epileptic focus, a small part of the brain that is the starting point of the seizure. This focus is like an irritant or an inflammation, and helps cause the seizure. People with epilepsy that affects the temporal lobe of the brain often have an epileptic focus. Researchers want to look at the epileptic focus by using a drug that attaches to a protein associated with inflammation. An imaging study with the drug will show how much inflammation is in the area of the brain where the seizures start. The drug, called \[11C\]DPA-713, will be tested for its effectiveness in people with temporal lobe epilepsy. Its effects will be compared with imaging studies given to healthy volunteers. Objectives: \- To see if \[11C\]DPA-713 can show the inflammation in the epileptic focus of seizures. Eligibility: * Individuals at least 18 years of age who have temporal lobe epilepsy. * Healthy volunteers at least 18 years of age. Design: * Participants will have three outpatient visits to the National Institutes of Health Clinical Center. The visits will last from 2 to 5 hours. * Participants will be screened with a physical exam, neurological exam, and medical history. Blood samples will be collected before the start of the study. * Participants will have a positron emission tomography (PET) scan. This scan will be used to look at brain chemistry and function. The study drug will be given during the scan to see how well it shows points of inflammation in the brain. Some participants will provide additional blood samples during the PET scan. * Participants will also have a magnetic resonance imaging (MRI) scan. This scan will look at the structure of the brain.

Conditions Studied

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2013-01-31
Est. Completion 2016-06-08

What the Registry Record Tells You About NCT01793532

The ClinicalTrials.gov registry entry for NCT01793532 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (96% lower). The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 0 interventions.

NCT01793532 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT01793532 about?

NCT01793532 is a clinical study titled "Study of [11C]DPA-713 for Temporal Lobe Epilepsy". Background: \- Some people with epilepsy have an epileptic focus, a small part of the brain that is the starting point of the seizure. This focus is like an irritant or an inflammation, and helps cause the seizure. People with epilepsy that affects the temporal lobe of the brain often have an epile...

What is the current status of trial NCT01793532?

This trial is currently completed. The enrollment target is 38 participants. The study started on 2013-01-31. Estimated completion is 2016-06-08.

What conditions does trial NCT01793532 study?

This clinical trial studies the following conditions: Epilepsy, Temporal Lobe.

Who is sponsoring clinical trial NCT01793532?

This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01793532 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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