Epilepsies, Partial Clinical Trial
Official title:
Positron Emission Tomography Measurement of Neuroinflammation in Focal Epilepsy
Background:
- The brain is protected by a barrier that keeps toxins in the blood from reaching the
brain. However, this barrier can also keep useful medications from reaching the brain.
P-glycoprotein (P-gp) is a brain protein that is part of the blood-brain barrier. The
level of P-gp is higher in people with epilepsy than in people without epilepsy. These
different levels of P-gp may explain why some people have seizures that do not respond
well to medications. Researchers want to see if P-gp can affect the response to epilepsy
medications.
- Epilepsy may also be associated with brain inflammation. Researchers also want to look
at the part of the brain affected by epilepsy to see if inflammation is present.
Objectives:
- To see if P-gp can affect the response to epilepsy medications.
- To see if inflammation is present in the part of the brain affected by epilepsy.
Eligibility:
- <TAB>Individuals between 18 and 60 years of age who have temporal lobe epilepsy. We plan
to study some patients whose seizures are well controlled by drugs, and some whose
seizures are not controlled.
- <TAB>
- Healthy volunteers between 18 and 60 years of age.
Design:
- This study requires four or five visits to the NIH Clinical Center over the course of a
year. The visits will be outpatient visits and will last from 2 to 5 hours.
- Participants will be screened with a physical exam and medical history. Blood and urine
samples will be collected.
- All participants will have two positron emission tomography (PET) scans. The scans will
take place during different visits. Different drugs will be used in each scan. One drug
will be used to temporarily block the effect of P-gp in the brain. The other drug will
show areas of inflammation in the brain.
- Participants with epilepsy will have a third PET scan. This scan will also look at P-gp
activity in the brain. However, it will not use the drug that blocks the effect of P-gp.
- All participants will also have one magnetic resonance imaging scan. This scan will help
show brain function.
Objectives:
1. To study the role of inflammation in focal epilepsy
2. To characterize the BBB state in patients with focal epilepsy using MRI, and compare the
results with PET imaging of inflammation
3. To study test-retest replicability of [11C]PBR28 PET scanning.
Study population:
50 participants with drug-resistant focal epilepsy, 25 participants with drug-responsive
focal epilepsy and 25 healthy volunteers.
Design:
Screening of enrolled participants will include a medical history, physical exam, and blood
and urine laboratory testing. Blood samples will also be used for genetic polymorphism study.
Healthy volunteers will receive one or two brain positron emission tomography (PET) scans
with [11C]PBR28. Epilepsy participants will receive one or two PET scans with [11C]PBR28).
Everyone will receive a brain magnetic resonance imaging (MRI). Some participants will also
have a second MRI with gadolinium infusion to measure blood-brain barrier permeability.
Outcome measures:
The primary outcome measure will be the amount of differential [11C]PBR28 uptake between the
epileptic focus and the homologous contralateral region. [11C]PBR28 distribution volume (VT)
will be measured using an arterial input function. We want to quantify the tracer VT in
regions of the brain distant from the epileptic focus, which may be affected by the disease.
We hypothesize that focal epilepsy will be associated with brain inflammation and, therefore,
that [11C]PBR28 uptake in the affected side of the brain will be higher than in the
contralateral side.
We will study the polymorphism of the translocator protein (TSPO), because TSPO polymorphism
has an influence on [11C]PBR28 binding. This polymorphism is due to the non-conservative
amino-acid substitution at position 147 from alanine to threonine (Ala147Thr) in the fifth
transmembrane domain of the TSPO protein.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00524030 -
Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures
|
Phase 3 | |
| Completed |
NCT00143143 -
Pregabalin Open-Label Extension Trial in Patients With Partial Seizures
|
Phase 3 | |
| Completed |
NCT00771927 -
Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures
|
N/A | |
| Completed |
NCT00236873 -
A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.
|
Phase 2 | |
| Completed |
NCT01745952 -
Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
|
N/A | |
| Completed |
NCT00772603 -
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
|
Phase 3 | |
| Completed |
NCT00280696 -
A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures
|
Phase 3 | |
| Completed |
NCT00643136 -
A Study of Lyrica as Treatment for Sleep Problems in Patients With Sleep Problems and Seizures
|
Phase 3 | |
| Completed |
NCT00230698 -
A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure
|
Phase 3 | |
| Completed |
NCT00072813 -
MRI in Autosomal Dominant Partial Epilepsy With Auditory Features
|
N/A | |
| Enrolling by invitation |
NCT04309812 -
Transcranial Direct Current to Treat Epilepsy at Home
|
Early Phase 1 | |
| Withdrawn |
NCT00422110 -
A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures
|
Phase 2/Phase 3 | |
| Completed |
NCT00620555 -
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
|
Phase 3 | |
| Completed |
NCT00448916 -
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
|
Phase 3 | |
| Completed |
NCT00210522 -
An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy
|
Phase 2 | |
| Completed |
NCT00236886 -
Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients
|
Phase 3 | |
| Completed |
NCT00236860 -
A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures
|
Phase 2 | |
| Active, not recruiting |
NCT03689114 -
Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)
|
Phase 4 | |
| Completed |
NCT01098162 -
Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug
|
N/A | |
| Completed |
NCT05273398 -
Effects of Diazepam on RNS Detections
|
Phase 4 |