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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 384 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Re-verified, no change to tracked fields
  4. New version filed on ClinicalTrials.gov
  5. 12 versions Re-verified since Jun 11, 2026, no change to tracked fieldsv369-v380
  6. Primary and study completion pushed from Jul 1, 2026 to Jul 1, 2030 Trial arms changed: 1 → 2 · Interventions: Mangafodipir (Drug) to Gadolinium (Drug), Mangafodipir (Drug)v368 Show 2 more changesShow less
    • Trial arms changed: 1 → 2
    • Interventions: Mangafodipir (Drug) to Gadolinium (Drug), Mangafodipir (Drug)
  7. 21 versions Re-verified since Jul 31, 2025, no change to tracked fieldsv347-v367
  8. Primary and study completion dates: Jul 1, 2025 to Jul 1, 2026v346
  9. 8 versions Re-verified since May 31, 2025, no change to tracked fieldsv338-v345
  10. Start date changed from estimate of May 10, 2025 to Nov 19, 2024v337
  11. 2 versions Re-verified since May 10, 2025, no change to tracked fieldsv335-v336
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02531880
Lead Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Epilepsy
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov