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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: Completed study of Epilepsy and Temporal Lobe, sponsored by National Institute of Mental Health (NIMH).
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. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2016-06-08 |
What the finished NCT01793532 record still lists
NCT01793532 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 0 interventions.
NCT01793532 reports a single indexed study location in 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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