Mangafodipir Imaging for Drug-Resistant Epilepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
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 requiredDesign:* 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, ongoing treatment with calcium-channel blockers is an exclusion criterion, so you may need to stop those if you are taking them.
How is mangafodipir imaging different from other drug-resistant epilepsy treatments?
What data supports the effectiveness of the drug Mangafodipir for drug-resistant epilepsy?
The research does not provide direct evidence for Mangafodipir's effectiveness in drug-resistant epilepsy, but it highlights the importance of MRI contrast agents in improving the visualization of epileptic areas, which is crucial for treatment planning in patients with drug-resistant epilepsy.678910
Who Is on the Research Team?
Sara K Inati, M.D.
Principal Investigator
National Institute of Neurological Disorders and Stroke (NINDS)
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with drug-resistant epilepsy, who have had seizures not controlled by medication for at least a year and experience at least one seizure monthly. Participants must be able to consent and should already be enrolled in protocol 18-N-0066. Exclusions include HIV positive individuals, pregnant or breastfeeding women, those with manganese allergies or certain medical conditions like Parkinson's disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mangafodipir through an IV and undergo MRI scans to assess blood-brain barrier disruption
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a final MRI scan
What Are the Treatments Tested in This Trial?
Interventions
- Mangafodipir
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Neurological Disorders and Stroke (NINDS)
Lead Sponsor