Epilepsy study: Mangafodipir vs Gadolinium
Official title Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
ClinicalTrials.gov ID: NCT02531880
What this study is testing
What is Mangafodipir?
An investigational contrast agent being studied for use in MRI scans to help identify areas of blood‑brain barrier breakdown in people with epilepsy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if mangafodipir is safe and well tolerated, and whether it can help MRI scans detect areas where the blood‑brain barrier is broken in people with epilepsy.
- Who it's for
- Adults aged 18 to 60 who have epilepsy that is not controlled by medication and are not already in another related study.
- What's involved
- Participants will have up to six visits over 1–3 months, including an inpatient stay of 2–10 days. They will receive IV injections of mangafodipir and gadolinium, undergo several MRI scans, and may have video‑EEG monitoring. Blood and urine tests and a physical exam will also be done.
- Time commitment
- The study lasts 1–3 months with up to six visits, including a 2–10 day hospital stay and several MRI scans during that time.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
You likely can't join if
- 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...
- Positive test for HIV
- 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.
See the full eligibility 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...
- 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
- 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.
- 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...
- History of post-ictal psychosis or post-ictal aggression
- Planning to get pregnant in the next 2 months
- 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 (people scoring 8 or higher on the AUDIT scale)
- Screening lab abnormalities demonstrating values more than 2 times the upper limit of normal for AST, ALT, bilirubin, alkaline phosphatase, BUN, creatinine
- Previous presumed occupational exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility, or agriculture)
- Allergy to manganese
- On-going treatment with calcium-channel blocker
- Iron-deficiency anemia
- Estimated GFR \<60, tested within 1 week of scan
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.