Back to resultsPerampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.
Primary Purpose
Epilepsy
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
perampanel
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Focal epilepsy, Perampanel
Eligibility Criteria
Inclusion Criteria:
- Age 18-65
- Stable focal epilepsy, with partial complex seizures including partial complex seizures with or without secondary generalization, partial simple seizures with a clear motor component with or without secondary generalization, and partial simple seizures with secondary generalization.
- Stable dose for at least 30 days of the chosen background AED dose
- Epilepsy duration for > 2 years
- Past/current treatment with > 4 AEDs. Vagal nerve stimulator treatment will be allowed and will not count as an AED. VNS setting must be stable for 3 months prior to enrollment.
- Seizure frequency of ≥1/month
Exclusion Criteria:
- Primary generalized epilepsy
- Simple partial seizures without motor components or secondary generalization
- Non-epileptic seizures
- Progressive neurological disease including growing neoplasm, CNS degenerative disorders including Alzheimer's disease, other forms of dementia
- Any systemic illness or unstable medical condition that might pose additional risk, including renal or liver disease, clinically uncontrolled cardiac disease, other unstable metabolic or endocrine disturbances, and active systemic cancer
- Change in the dose of any Antiepileptic Drug within 30 days prior to enrollment
- Psychosis within six months of enrollment.
- Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
- Pregnancy
- Use of any CNS-active investigational drugs within 3 months of enrollment.
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Sites / Locations
- MidAtlantic Epilepsy and Sleep Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
phenobarbital
valproate
lamotrigine
levetiracetam
zonisamide
pregabalin
lacosamide
clobazam
ezogabine
eslicarbazepine
topiramate
tiagabine
Arm Description
After 12 weeks of baseline observation on phenobarbital medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on valproate medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on lamotrigine medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on levetiracetam medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on zonisamide medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on pregabaline medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on lacosasmide medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on clobazam medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on ezogabine medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.
After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.
Outcomes
Primary Outcome Measures
responder rate
responder rate, defined by >75% seizure frequency reduction. Average seizure frequency per 4 weeks will be compared between the 12 weeks of "PMP+" maintenance treatment and 12 weeks of baseline.
seizure freedom rate
seizure freedom rate. Proportion of responders and of subjects with seizure freedom in each treatment arm will be compared with historical data of 75% seizure reduction from pivotal phase 3 studies for which such data is publicly available
treatment discontinuation rate
To evaluate the safety and tolerability of each perampanel+ combination with treatment discontinuation rate as the primary safety/tolerability outcome measure
Secondary Outcome Measures
Full Information
NCT ID
NCT02727101
First Posted
March 29, 2016
Last Updated
August 28, 2017
Sponsor
Mid-Atlantic Epilepsy and Sleep Center, LLC
Collaborators
Eisai Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02727101
Brief Title
Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.
Official Title
"Rational Polytherapy" Using Perampanel Dual Therapy Anticonvulsant Combination Treatments of Adults With Refractory Focal Epilepsy : a Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment
Study Start Date
November 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mid-Atlantic Epilepsy and Sleep Center, LLC
Collaborators
Eisai Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of the present study is to evaluate ("screen") a large number (12) of different dual therapies of perampanel + another AED ("PMP+") for a large, 75-100% seizure frequency reduction. The design of the study will differ from usual AED studies. The study will be (i) open label, with (ii) a small n per group, n=6, with (iii) outcome measures a 'blockbuster effect': (a) ≥75 seizure frequency reduction; and (b) seizure freedom.
Detailed Description
Investigators will compare rates of seizure freedom and >75% seizure frequency reduction among 12 treatment arms consisting of 6 subjects each with refractory focal epilepsy treated with perampanel and one other AED ("PMP+"). Treatment arms will include (1) Perampanel +phenobarbital, (2) PMP+valproate, (3) PMP+ lamotrigine, (4) PMP + topiramate, (5) PMP + tiagabine, (6) PMP + levetiracetam, (7) PMP + zonisamide, (8) PMP + pregabalin, (9) PMP + lacosamide, (10) PMP+ clobazam, (11) PMP + ezogabine; and (12) PMP + eslicarbazepine. Each group of 6 will be followed for 12 weeks of baseline observation on baseline medication. Seizure frequency will be counted, using subjects' self-reported seizure diaries. PMP will be titrated to 8-12 mg/day, with the final dose determined by side effects and tolerability of PMP at 8-12 mg/day doses. Titration will occur at the rate of 2 mg/week or two weeks (in accordance with FDA labeling), as tolerated. Subjects will be observed for 12 weeks of maintenance treatment on the target PMP doses. Seizure frequency will be compared between the 12 weeks of baseline observation and 12 weeks of maintenance treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Focal epilepsy, Perampanel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
phenobarbital
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on phenobarbital medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
valproate
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on valproate medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
lamotrigine
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on lamotrigine medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
levetiracetam
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on levetiracetam medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
zonisamide
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on zonisamide medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
pregabalin
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on pregabaline medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
lacosamide
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on lacosasmide medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
clobazam
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on clobazam medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
ezogabine
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on ezogabine medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
eslicarbazepine
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
topiramate
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.
Arm Title
tiagabine
Arm Type
Active Comparator
Arm Description
After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.
Intervention Type
Drug
Intervention Name(s)
perampanel
Other Intervention Name(s)
Fycompa
Intervention Description
Each group of 6 patients will be followed for 12 weeks of baseline observation on baseline medication. Seizure frequency will be counted, using subjects' self-reported seizure diaries. Perampanel will be titrated to 8-12 mg/day, with the final dose determined by side effects and tolerability of Perampanel at 8-12 mg/day doses. Titration will occur at the rate of 2 mg/week or two weeks, as tolerated.
Primary Outcome Measure Information:
Title
responder rate
Description
responder rate, defined by >75% seizure frequency reduction. Average seizure frequency per 4 weeks will be compared between the 12 weeks of "PMP+" maintenance treatment and 12 weeks of baseline.
Time Frame
12 weeks
Title
seizure freedom rate
Description
seizure freedom rate. Proportion of responders and of subjects with seizure freedom in each treatment arm will be compared with historical data of 75% seizure reduction from pivotal phase 3 studies for which such data is publicly available
Time Frame
12 weeks
Title
treatment discontinuation rate
Description
To evaluate the safety and tolerability of each perampanel+ combination with treatment discontinuation rate as the primary safety/tolerability outcome measure
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65
Stable focal epilepsy, with partial complex seizures including partial complex seizures with or without secondary generalization, partial simple seizures with a clear motor component with or without secondary generalization, and partial simple seizures with secondary generalization.
Stable dose for at least 30 days of the chosen background AED dose
Epilepsy duration for > 2 years
Past/current treatment with > 4 AEDs. Vagal nerve stimulator treatment will be allowed and will not count as an AED. VNS setting must be stable for 3 months prior to enrollment.
Seizure frequency of ≥1/month
Exclusion Criteria:
Primary generalized epilepsy
Simple partial seizures without motor components or secondary generalization
Non-epileptic seizures
Progressive neurological disease including growing neoplasm, CNS degenerative disorders including Alzheimer's disease, other forms of dementia
Any systemic illness or unstable medical condition that might pose additional risk, including renal or liver disease, clinically uncontrolled cardiac disease, other unstable metabolic or endocrine disturbances, and active systemic cancer
Change in the dose of any Antiepileptic Drug within 30 days prior to enrollment
Psychosis within six months of enrollment.
Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
Pregnancy
Use of any CNS-active investigational drugs within 3 months of enrollment.
Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Klein, M.B,B.Chir.
Organizational Affiliation
Mid-Atlantic Epilepsy and Sleep Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MidAtlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.
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