Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04650204
Status:
TERMINATED
Last Update Posted:
2023-06-22
First Post:
2020-11-11
Brief Title:
Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase IV Prospective Open-Label Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication Using a Glutamatergic Modulator in Patients With Focal Epilepsy and High-Grade Glioma
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The funding sponsor EISAI sold the US rights to the medication and can no longer provide it to patients for the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IV trial studies the side effects and how well perampanel works in reducing seizure frequency in patients with high-grade glioma and focal epilepsy Perampanel is a drug used to treat seizures Giving perampanel together with other anti-seizure drugs may work better in reducing seizure frequency in patients with high-grade glioma and focal epilepsy compared to alternate anti-seizure drugs alone
Detailed Description:
PRIMARY OBJECTIVE
I Demonstrate the efficacy and safety of perampanel PER on seizure frequency in adult patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate anti-seizure drugs ASDs
SECONDARY OBJECTIVES
I To assess the change in neurocognitive function and brain magnetic resonance imaging MRI progression over the course of PER treatment with a daily dose of 4 mg up to -8mg in patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate ASDs
II To identify a biomarker-specific response to seizure-reduction in patients treated with PER in patients with a biopsy-proven high-grade glioma ie IDH-mutant versus vs wildtype
OUTLINE Patients are assigned to 1 of 2 groups
GROUP A Patients receive perampanel orally PO once daily QD for 40 weeks in the absence of disease progression or unacceptable toxicity
GROUP B Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 12 months
I Demonstrate the efficacy and safety of perampanel PER on seizure frequency in adult patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate anti-seizure drugs ASDs
SECONDARY OBJECTIVES
I To assess the change in neurocognitive function and brain magnetic resonance imaging MRI progression over the course of PER treatment with a daily dose of 4 mg up to -8mg in patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate ASDs
II To identify a biomarker-specific response to seizure-reduction in patients treated with PER in patients with a biopsy-proven high-grade glioma ie IDH-mutant versus vs wildtype
OUTLINE Patients are assigned to 1 of 2 groups
GROUP A Patients receive perampanel orally PO once daily QD for 40 weeks in the absence of disease progression or unacceptable toxicity
GROUP B Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MC2072 | OTHER | Mayo Clinic | None |
| NCI-2020-01290 | REGISTRY | None | None |