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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT01793532
First received: February 14, 2013
Last updated: August 6, 2014
Last verified: November 2013
  Purpose

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.

Condition Phase
Epilepsy
Temporal Lobe
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of [11C]DPA-713 in Temporal Lobe Epilepsy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Brain uptake of radioligand [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

For healthy volunteers

  • Age 18 or older.
  • Able to give written informed consent.
  • No prior diagnosis of drug or alcohol abuse or dependence.

For patients

  • Age 18 or older.
  • Able to give written informed consent.
  • Having clinically documented partial seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, which may be refractory or responsive to standard antiepileptic treatment. This criterion will be established by preliminary screening in the NINDS Clinical Epilepsy Section outpatient clinic under protocol 01-N-0139, and if necessary, inpatient video-EEG monitoring. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies.
  • Negative toxicology testing at the time of screening.
  • No prior diagnosis of drug or alcohol abuse or dependence.

EXCLUSION CRITERIA:

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.
  • For drug-responsive subjects: occurrence of a seizure within the last three months.
  • Drug/alcohol abuse or dependence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793532

Contacts
Contact: Patricia M Reeves-Tyer, R. EEG T. (301) 496-1923 tyerp@ninds.nih.gov
Contact: Robert B Innis, M.D. (301) 594-1368 robert.innis@nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Robert B Innis, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT01793532     History of Changes
Other Study ID Numbers: 130070, 13-M-0070
Study First Received: February 14, 2013
Last Updated: August 6, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
PET Imaging
Epilepsy
Inflammation
Brain Imaging

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial

ClinicalTrials.gov processed this record on August 28, 2014