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

Completed

Conditions studied: Epilepsy, Temporal Lobe

In brief

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.

Key facts

Study ID

NCT01793532

Run by

National Institute of Mental Health (NIMH)

People needed

38

Starts

2013-01-31

Expected to finish

2016-06-08

Last updated by the study team

2019-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• For healthy volunteers
• Any current Axis I diagnosis.
• Clinically significant laboratory abnormalities.
• Positive test for HIV.
• Unable to have a MRI scan.
• History of neurologic illness or injury with the potential to affect study data interpretation.
• History of seizures, other than in childhood and related to fever.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Inability to lie flat on camera bed for at least two hours.
• Pregnancy or breast feeding.
• Able to get pregnant but does not use birth control.
• Drug/alcohol abuse or dependence
• For patients
• Previous radiation exposure (X-rays, PET scans etc.) that, together with study procedures, would exceed NIH RSC research limits.
• Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine.
• History of brain disease other than epilepsy.
• Cannot lie on their back for at least two hours.
• Known cause for seizures, other than mesial temporal sclerosis, such as tumor or infection.
• Serious medical illness, other than epilepsy.
• Clinically significant laboratory abnormalities.
• Positive test for HIV.
• Brain abnormality such as a brain tumor, stroke, brain damage from head trauma or blood vessel abnormalities, on an MRI scan.
• Pregnancy or breast feeding.
• Able to get pregnant but does not use birth control.
• Risk for MRI scan, such as a pacemaker or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments. Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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