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NCT02531880 · ClinicalTrials.gov registry record · Phase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
A Phase 1 study of Epilepsy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02531880: Recruiting Phase 1 study of Epilepsy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT02531880 is a Phase 1 study of Epilepsy that is actively recruiting participants, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 40 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02531880, a Phase 1 study of Epilepsy, is actively recruiting participants, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
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....
Primary Outcome
safety profile
Conditions Studied
Interventions
- DRUG Mangafodipir
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-11-19 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 1 |
What NCT02531880 shows while recruiting
NCT02531880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Mangafodipir is the first listed.
NCT02531880 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02531880 about?
NCT02531880 is a clinical study titled "Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy". 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. O...
What is the current status of trial NCT02531880?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-11-19. Estimated completion is 2026-07-01.
What conditions does trial NCT02531880 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT02531880?
The interventions under investigation include: Mangafodipir (DRUG).
Who is sponsoring clinical trial NCT02531880?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02531880 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02531880's enrollment target sits among peer trials
40 92nd of 160 higher than 61 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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