NCT02531880RecruitingPhase 1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

Background: \- The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures. It can affect this barrier. Researchers think a contrast agent called mangafodipir might be better able to show areas of the brain that epilepsy affects. Objective: \- To see if mangafodipir is well tolerated and safe. To see if magnetic resonance imaging (MRI) using either mangafodipir or gadolinium can show areas of blood-brain barrier breakdown in people with epilepsy. Eligibility: * People ages 18-60 who: * Have epilepsy not controlled by drugs * Prior or concurrent enrollment in 18-N-0066 is required Design: * Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Participants will have up to 6 visits in 1-3 months. One visit is an inpatient stay lasting 2-10 days. Visits may include: * Video-EEG monitoring for participants with epilepsy * An IV catheter put in place: a needle guides a thin plastic tube into an arm vein. * Getting mangafodipir through the IV. * Getting gadolinium through the IV. * Up to 6 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides into a metal cylinder. They are in the cylinder for 45-90 minutes, lying still for up to 10 minutes at a time. The scanner makes loud knocking sounds. Participants will get earplugs. * A final MRI at least 2 weeks after receiving mangafodipir.

Status (registry): Recruiting
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 40 (estimated)
First submitted: 22 Aug 2015
Start date: 19 Nov 2024
Primary completion date: 1 Jul 2030
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Diseases: Epilepsy
NCT number: NCT02531880

What you commit to

Study type: Interventional · Phase 1
Planned participants: 40
From 19 Nov 2024 to the primary completion date, 1 Jul 2030
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous presumed occupational exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility, or agriculture)

Other illness

Patients with epilepsy who are not surgical candidates
Significant structural brain abnormality such as a brain tumor, stroke, brain damage from head trauma or blood vessel abnormalities, on the baseline MRI scan.
Positive test for HIV
Risk for MRI scan, (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed, or history of being a welder or metal worker due to small metal fragments in the eye)
History of post-ictal psychosis or post-ictal aggression
History of clinically significant liver or kidney disease that could potentially increase the risk of CNS damage due to manganese exposure
A history of drug or alcohol abuse/dependence (subjects scoring 8 or higher on the AUDIT scale)
Allergy to manganese
Personal history of Parkinson s Disease or Parkinsonism or presence of this disease in a 1st degree relative
- Gadolinium enhanced MRI component specific exclusions (applicable only to patients participating in this arm of the study):
Allergy to gadolinium
- Of note, patients who are ineligible for one arm of the study may still be eligible for and participate in the other arm of the study.

Lab values

Screening lab abnormalities demonstrating values more than 2 times the upper limit of normal for AST, ALT, bilirubin, alkaline phosphatase, BUN, creatinine
On-going treatment with calcium-channel blocker
Estimated GFR \<60, tested within 1 week of scan

Other

General exclusions:
Pregnancy or breast-feeding
Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine.
Cannot lie on their back for at least two hours.
Unwilling to allow sharing and/or use in future studies of coded data that are collected for this study
- MEMRI component specific exclusions (applicable only to patients participating in this arm of the study):
Planning to get pregnant in the next 2 months
Iron-deficiency anemia

Criteria the registry did not label

INCLUSION CRITERIA:
Age 18-60.
Able to give written informed consent directly.
Drug resistant epilepsy participants will be defined as having clinically documented seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard anti-seizure treatment for at least one year prior to enrolling in this study and with an average of at least one seizure per month. This criterion will be established by preliminary screening NINDS Epilepsy Service under protocol 18-N-0066. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies. Prior or concurrent enrollment in 18-N-0066 is required.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.