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Mangafodipir Imaging for Drug-Resistant Epilepsy

Phase 1

Recruiting

Led By Sara K Inati, M.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-60

Drug resistant epilepsy participants with clinically documented seizures and consistent EEG evidence refractory to standard anti-seizure treatment for at least one year, with an average of at least one seizure per month

Must not have

Personal history of Parkinson's Disease or Parkinsonism

On-going treatment with calcium-channel blocker

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after mangafodipir adminstration

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a contrast agent called mangafodipir is better able to show areas of the brain that epilepsy affects. It is for people ages 18-60 who have epilepsy that is not controlled by drugs.

Who is the study for?

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.

What is being tested?

The study tests if mangafodipir can safely highlight brain areas affected by epilepsy on MRI scans. Participants will undergo multiple visits over 1-3 months including an inpatient stay of 2-10 days for video EEG monitoring, IV catheter placement, administration of mangafodipir, and several MRI scans before and after the contrast agent is given.

What are the potential side effects?

Potential side effects from mangafodipir may include discomfort from the IV insertion and reactions to the contrast agent such as mild allergic responses. The MRI process can cause anxiety due to loud noises (earplugs are provided) or claustrophobia inside the scanner.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I have epilepsy that hasn't improved with treatment for over a year, with at least one seizure a month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Parkinson's Disease or Parkinsonism.

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I am currently taking medication for my blood pressure.

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I have epilepsy and cannot have surgery.

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I have experienced psychosis or aggression after seizures.

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I cannot lie on my back for two hours.

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I have anemia caused by not having enough iron.

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My kidney function is reduced, with a GFR under 60.

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I have a history of serious liver or kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after mangafodipir administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after mangafodipir administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and after mangafodipir administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

description of the safety profile of mangafodipir administration in patients with epilepsy

evaluation of the utility of MEMRI and/or DCE-MRI in identifying focal BBBD in the seizure onset zone identified by standard clinical, EEG, and imaging studies, and the homologous contralateral region.