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Mangafodipir Imaging for Drug-Resistant Epilepsy

Phase 1
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after mangafodipir adminstration
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
description of the safety profile of mangafodipir administration in patients with epilepsy
Brain

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Patients will be given the study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mangafodipir
2008
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,335 Previous Clinical Trials
648,491 Total Patients Enrolled
76 Trials studying Epilepsy
24,908 Patients Enrolled for Epilepsy
Sara K Inati, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
5 Previous Clinical Trials
2,847 Total Patients Enrolled
3 Trials studying Epilepsy
2,778 Patients Enrolled for Epilepsy

Media Library

Mangafodipir Clinical Trial Eligibility Overview. Trial Name: NCT02531880 — Phase 1
Epilepsy Research Study Groups: 1
Epilepsy Clinical Trial 2023: Mangafodipir Highlights & Side Effects. Trial Name: NCT02531880 — Phase 1
Mangafodipir 2023 Treatment Timeline for Medical Study. Trial Name: NCT02531880 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there known adverse effects for using Mangafodipir therapeutically?

"In light of Mangafodipir's Phase 1 status, with limited evidence for safety and efficacy, our team assigned it an assessment score of 1."

Answered by AI

What criteria must a person meet to be included in this research project?

"The study is open to 20 participants suffering from aura, with ages ranging between 18 and 60. Eligible individuals must meet the following prerequisites: Ages within 18-60 years old; drug resistant epilepsy as evidenced by consistent EEG findings according to the 1981 International Classification of Epileptic Seizures not responding well to anti-seizure treatments for at least a year before enrollment in this trial, including an average of one seizure per month; localization of seizures focus established via conventional clinical, neurophysiological and imaging studies; prior or concurrent participation in protocol 18-N-0066 handled through NINDS Clinical Epilepsy Service."

Answered by AI

Are participants still being accepted for this clinical experiment?

"Indicated by clinicaltrials.gov, this trial is no longer recruiting patients; it was initially posted on November 6th 2023 and the most recent update to its profile occurred on November 22nd 2022. In spite of this particular study's closure, 249 other medical trials are actively searching for participants at present."

Answered by AI

Has Mangafodipir been investigated in previous research?

"Currently, there is a single clinical trial actively studying the effects of mangafodipir. This Phase 3 study has not yet begun, however two locations in Bethesda Maryland are ready to open recruitment for this research."

Answered by AI

How many subjects are actively engaging in the research endeavor?

"This research initiative is no longer seeking participants. The trial was posted on November 6th 2023 and last updated on November 22nd 2022. Currently, there are 248 clinical trials for aura patients that are still accepting members and one Mangafodipir study recruiting individuals as well."

Answered by AI

Does this research protocol stipulate any age restrictions?

"This medical trial is open to any patient between 18 and 60 years of age. For those that fall outside this range, there are 105 clinical studies available for minors as well as 165 trials designed for seniors."

Answered by AI
~27 spots leftby Jul 2024