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NCT01663545 · ClinicalTrials.gov registry record
Brain P-gp and Inflammation in People With Epilepsy
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 38
- Enrollment target
NCT01663545 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 38 participants.
The verdict
NCT01663545 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
Study Summary
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-07-31 |
| Est. Completion | 2017-10-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01663545
The ClinicalTrials.gov registry entry for NCT01663545 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01663545 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01663545 about?
NCT01663545 is a clinical study titled "Brain P-gp and Inflammation in People With 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 ...
What is the current status of trial NCT01663545?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2012-07-31. Estimated completion is 2017-10-04.
Who is sponsoring clinical trial NCT01663545?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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