Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02363933
Status:
COMPLETED
Last Update Posted:
2018-04-27
First Post:
2015-02-10
Brief Title:
Perampanel in Seizure Patients With Primary Glial Brain Tumors
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Feasibility Study to Evaluate the Efficacy and Safety of Perampanel in Seizure Patients With Primary Glial Brain Tumors
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive anti-epileptic drug AED in patients with primary glioma that are presenting refractory partial onset seizure activity defined as 3 or more seizures in a 28-day period In this study patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime for 2 weeks At the start of week 3 perampanel will be titrated up in dose in 2mg increments per week up to 8mg daily as long as it is well tolerated by the patient The highest dose of perampanel will be 8 mg orally at bedtime Once this is achieved patients will remain on a maintenance dose of 8 mg for 12 more weeks The planned treatment dose is 8mg but the dose can be modified by the physician based on patient reported tolerability Titration and taper periods will be determined by the physician in the case where patients do not reach the planned treatment dose of 8 mg daily Patients will be assessed in the Brain Tumor Center Clinic every 8 weeks Study assessments will be made at enrollment 8 weeks 16 weeks and 24 weeks Assessments will include history and physical examination HP including Karnofsky Performance Status KPS neurological examination evaluation of seizure history patient-reported outcomes of QoL and computer based neurocognitive testing After a total of 16 weeks of therapy perampanel will be tapered down At Week 17 patients will begin taking 6mg of perampanel Week 18 4mg Week 19 2mg and Week 20 they will no longer take perampanel Patients will be considered off treatment at the end of week 20 once perampanel has cleared their system Patients will then be monitored through Week 24 Patients will continue to take their original AED regimen after they stop perampanel If seizure control is achieved during the maintenance period or if seizures occur during the tapering period patients can be continued on perampanel per the discretion of the treating physician In this instance perampanel will be prescribed by the treating physician and not provided within the confines of the study Efficacy will be assessed using a log of patient-reported seizure activity As is standard procedure at the Preston Robert Tisch Brain Tumor Center PRTBTC patients will be given a log to record the number of seizures that occur Research team members will regularly contact patients for reminders and reports from the log Safety will be assessed with the following laboratory evaluations complete blood count CBC with differential complete metabolic panel CMP and toxicity assessment
Detailed Description:
This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive anti-epileptic drug AED in patients with primary glioma that are presenting refractory partial onset seizure activity defined as 3 or more seizures in a 28-day period In this study patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime for 2 weeks At the start of week 3 perampanel will be titrated up in dose in 2mg increments per week up to 8mg daily as long as it is well tolerated by the patient The highest dose of perampanel will be 8 mg orally at bedtime Once this is achieved patients will remain on a maintenance dose of 8 mg for 12 more weeks The planned treatment dose is 8mg but the dose can be modified by the physician based on patient reported tolerability Titration and taper periods will be determined by the physician in the case where patients do not reach the planned treatment dose of 8 mg daily Patients will be assessed in the Brain Tumor Center Clinic every 8 weeks Study assessments will be made at enrollment 8 weeks 16 weeks and 24 weeks Assessments will include history and physical examination HP including Karnofsky Performance Status KPS neurological examination evaluation of seizure history patient-reported outcomes of QoL and computer based neurocognitive testing After a total of 16 weeks of therapy perampanel will be tapered for 3 weeks and then will be discontinued such that Week 20 patients will no longer be taking perampanel Patients will then be monitored through Week 24 Patients will continue to take their original AED regimen after they stop perampanel Patients will remain on their original AED regimen during this treatment time and the dose of their original AED regimen at the start of the study will not be changed while they are on study If seizure control is achieved during the maintenance period or if seizures occur during the tapering period patients can be continued on perampanel per the discretion of the treating physician In this instance perampanel will be prescribed by the treating physician and not provided within the confines of the study Efficacy will be assessed using a log of patient-reported seizure activity As is standard procedure at the PRTBTC patients will be given a log to record the number of seizures that occur Research team members will regularly contact patients for reminders and reports from the log Safety will be assessed with the following laboratory evaluations complete blood count CBC with differential complete metabolic panel CMP and toxicity assessment
This study has been designed with 90 power to detect an increase in the 50 responder rate during the maintenance period from a benchmark of 20 to 35 Assuming a type I error rate of 01 61 patients will be required Based on prior studies the early discontinuation rate was 16 therefore 71 patients will be enrolled to compensate for patients discontinuing prior to the completion of the maintenance period
This study has been designed with 90 power to detect an increase in the 50 responder rate during the maintenance period from a benchmark of 20 to 35 Assuming a type I error rate of 01 61 patients will be required Based on prior studies the early discontinuation rate was 16 therefore 71 patients will be enrolled to compensate for patients discontinuing prior to the completion of the maintenance period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None