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

NCT02531880 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-01

No results posted yet for this study

Summary

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 it can show, on an MRI, areas of the brain that epilepsy affects.

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. Those with epilepsy will have 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.
* 5 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. Gadolinium is given through an IV catheter....

Conditions

Interventions

DRUG

Mangafodipir

Patients will be imaged interictally with a gadolinium enhanced MRI session. The administration of mangafodipir will be done as an inpatient during long-term video EEG recording, to ensure administration in the peri-ictal period.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Sara K Inati, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2026-07-01
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02531880 on ClinicalTrials.gov