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Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.

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ClinicalTrials.gov Identifier: NCT02727101
Recruitment Status : Terminated (slow enrollment)
First Posted : April 4, 2016
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 4, 2016
Last Update Posted Date August 29, 2017
Study Start Date  ICMJE November 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • responder rate [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 weeks ]
    To evaluate the safety and tolerability of each perampanel+ combination with treatment discontinuation rate as the primary safety/tolerability outcome measure
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02727101 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.
Official Title  ICMJE "Rational Polytherapy" Using Perampanel Dual Therapy Anticonvulsant Combination Treatments of Adults With Refractory Focal Epilepsy : a Pilot Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: perampanel
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.
Other Name: Fycompa
Study Arms  ICMJE
  • Active Comparator: phenobarbital
    After 12 weeks of baseline observation on phenobarbital medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: valproate
    After 12 weeks of baseline observation on valproate medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: lamotrigine
    After 12 weeks of baseline observation on lamotrigine medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: levetiracetam
    After 12 weeks of baseline observation on levetiracetam medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: zonisamide
    After 12 weeks of baseline observation on zonisamide medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: pregabalin
    After 12 weeks of baseline observation on pregabaline medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: lacosamide
    After 12 weeks of baseline observation on lacosasmide medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: clobazam
    After 12 weeks of baseline observation on clobazam medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: ezogabine
    After 12 weeks of baseline observation on ezogabine medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: eslicarbazepine
    After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: topiramate
    After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
  • Active Comparator: tiagabine
    After 12 weeks of baseline observation on eslicarbamazepine medication, the treatment with perampanel will introduced as "add on" medication.
    Intervention: Drug: perampanel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2016)
72
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-65
  2. 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.
  3. Stable dose for at least 30 days of the chosen background AED dose
  4. Epilepsy duration for > 2 years
  5. 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.
  6. Seizure frequency of ≥1/month

Exclusion Criteria:

  1. Primary generalized epilepsy
  2. Simple partial seizures without motor components or secondary generalization
  3. Non-epileptic seizures
  4. Progressive neurological disease including growing neoplasm, CNS degenerative disorders including Alzheimer's disease, other forms of dementia
  5. 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
  6. Change in the dose of any Antiepileptic Drug within 30 days prior to enrollment
  7. Psychosis within six months of enrollment.
  8. Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements;
  9. Pregnancy
  10. Use of any CNS-active investigational drugs within 3 months of enrollment.
  11. Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02727101
Other Study ID Numbers  ICMJE maes 008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC
Study Sponsor  ICMJE Mid-Atlantic Epilepsy and Sleep Center, LLC
Collaborators  ICMJE Eisai Inc.
Investigators  ICMJE
Principal Investigator: Pavel Klein, M.B,B.Chir. Mid-Atlantic Epilepsy and Sleep Center
PRS Account Mid-Atlantic Epilepsy and Sleep Center, LLC
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP