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New treatment option for Epilepsy, Temporal Lobe
Official title Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy
ClinicalTrials.gov ID: NCT06483061
What this study is testing
What is Ferumoxytol?
Ferumoxytol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for epilepsy, temporal lobe.
Also referred to as Feraheme.
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
- Temporal lobe epilepsy (TLE) is a common type of epilepsy and one of the most likely to not be controlled by medication. For patients who do not respond to medication, surgery can result in a cure of seizures.
- Phase 2: a mid-size study of how well it works
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 64. Healthy volunteers may be eligible.
You may be able to join if
- Healthy controls aged 18-64.
- Patients with temporal lobe epilepsy aged 18-64 and hippocampal sclerosis demonstrated on clinical MRI scan
You likely can't join if
- Non-English speaking participants will be excluded as we cannot provide translation services.
- Inability to provide informed consent.
- Contraindications to MRI Age \ 65 years
- Weight \> 127.5kg (which is the maximum weight of which a single 510mg vial of Ferumoxytol would accommodate a 4mg/kg dose).
- Women of childbearing capacity with a positive pregnancy test
- Women who are actively breast feeding
See the full eligibility criteria
- Healthy controls aged 18-64.
- Patients with temporal lobe epilepsy aged 18-64 and hippocampal sclerosis demonstrated on clinical MRI scan
- Non-English speaking participants will be excluded as we cannot provide translation services.
- Inability to provide informed consent.
- Contraindications to MRI Age \ 65 years
- Weight \> 127.5kg (which is the maximum weight of which a single 510mg vial of Ferumoxytol would accommodate a 4mg/kg dose).
- Women of childbearing capacity with a positive pregnancy test
- Women who are actively breast feeding
- Contraindication of Ferumoxytol -known hypersensitivity to Feraheme or any of its components -History of allergic reaction to any intravenous iron product
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
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 - 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 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.