SNPMiner Trials (Home Page)
Report for Clinical Trial NCT01663545
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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:
- 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.
-
- 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.
NCT01663545 Epilepsies, Partial
Primary Outcomes
Measure: Amount of differential [11C]dLop and [11C]PBR28 uptake between the epileptic focus and the homologous contralateral region Time: study completion
Secondary Outcomes
Measure: Secondary Outcome Measure: A secondary goal is to determine if inhibiting P-gp with tariquidar results in increased concentrations of anti-epileptic medications into the CSF, as a surrogate marker for increased penetration of these medication... Time: study completion
Time Perspective: Prospective
Cohort
There is one SNP
SNPs
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. --- Ala147Thr ---
HPO Nodes