Study of [11C]DPA-713 for Temporal Lobe Epilepsy
- 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.
- To see if [11C]DPA-713 can show the inflammation in the epileptic focus of seizures.
- Individuals at least 18 years of age who have temporal lobe epilepsy.
- Healthy volunteers at least 18 years of age.
- 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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Assessment of [11C]DPA-713 in Temporal Lobe Epilepsy|
- Brain uptake of radioligand [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01793532
|Contact: Patricia M Reeves-Tyer, R. EEG T.||(301) firstname.lastname@example.org|
|Contact: Robert B Innis, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Robert B Innis, M.D.||National Institute of Mental Health (NIMH)|