RECRUITING

A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).

Official Title

An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy

Quick Facts

Study Start:2019-05-31
Study Completion:2026-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04015141

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female participants. Cohort 1: age 1 month to less than 18 years; Cohort 2: age 1 month to less than 2 years at the time of informed consent/assent. Participants below the age of 1 year must have been at least 36 weeks of gestational age at birth.
  2. * Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2).
  3. * Have had equal or greater than 4 seizures over the 4-week interval prior to enrollment visit.
  4. * Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging (example, magnetic resonance imaging \[MRI\] scan or computed tomography \[CT\] or ultrasound \[for less than 1 year old\]).
  5. * Currently maintained on stable doses of 1 to a maximum of 4 approved antiepileptic drugs (AEDs). A prescription medical marijuana (including products containing cannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot be the only concomitant AED if this product is not an approved AED in the country where the study site is located. Doses must be stable for at least 4 weeks (at least 2 weeks for participant less than \[\<\] 6 months old) before Visit 1/Baseline or screening; only 1 enzyme-inducing antiepileptic drug (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4 AEDs is allowed.
  1. * Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before screening visit.
  2. * Have a history of status epilepticus that required hospitalization within 6 months before screening visit.
  3. * Have an unstable psychiatric diagnosis that may confound participant's ability to participate in the study or that may prevent completion of the protocol specified tests (example, significant suicide risk, including suicidal behavior and ideation within 6 months before screening visit 1, current psychotic disorder, acute mania).
  4. * Any suicidal ideation with intent with or without a plan within 6 months before enrollment visit (answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) in participants aged 6 and above or based on the opinion of the Investigator for participants less than 6 years.
  5. * Are scheduled or confirmed or both to have epilepsy surgery within 6 months after screening visit; however, those who have previously documented "failed" epilepsy surgery will be allowed.
  6. * Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  7. * Benzodiazepines for any indications other than epilepsy (example, anxiety/sleep disorders) prohibited from 1 month before Visit 1/Baseline or screening and during the study. Benzodiazepines for seizure control and as rescue medication are allowed.
  8. * A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS) implanted less than 5 months before screening visit or changes in parameter less than 4 weeks before screening visit (or thereafter during the study).
  9. * Use of perampanel within 30 days before screening visit, or perampanel was discontinued due to adverse reactions (perampanel-related) or lack of efficacy in case of previous exposure.
  10. * Weight less than 4.0 kilogram (kg) at Visit 1 (Baseline or screening).

Contacts and Locations

Study Contact

Eisai Medical Information
CONTACT
+1-888-274-2378
esi_medinfo@eisai.com

Study Locations (Sites)

Phoenix Childrens Hospital
Phoenix, Arizona, 85016
United States
Center For Neurosciences
Tucson, Arizona, 85718
United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-3075
United States
Childrens Hospital Colorado
Aurora, Colorado, 80045-7106
United States
Nemours Foundation Alfred Dupont Children's Hospital
Wilmington, Delaware, 19803
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
Pediatric Neurology PA
Orlando, Florida, 32819
United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, 33607
United States
Meridian Clinical Research-(Savannah Georgia)
Savannah, Georgia, 31406
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, 07601
United States
Columbia University Medical Center
New York, New York, 10032
United States
Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, 27157
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Dayton Children's Hospital
Dayton, Ohio, 45404
United States
Doernbecher Children's Hospital
Portland, Oregon, 97239
United States
Child Neurology Consultants of Austin
Austin, Texas, 78731
United States
Road Runner Research Ltd
San Antonio, Texas, 78249
United States
Children's Specialty Group
Norfolk, Virginia, 23510
United States
Children's Hospital of Richmond at VCU - CHoR-PIN
Richmond, Virginia, 23298
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Eisai Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-31
Study Completion Date2026-12-23

Study Record Updates

Study Start Date2019-05-31
Study Completion Date2026-12-23

Terms related to this study

Keywords Provided by Researchers

  • Partial-onset seizures
  • Pediatric epileptic syndrome
  • Epilepsy
  • Childhood epilepsy
  • Epilepsy in children
  • Refractory seizures
  • Inadequately controlled seizures
  • E2007
  • Fycompa
  • Perampanel

Additional Relevant MeSH Terms

  • Pediatric Epileptic Syndrome
  • Partial-onset Seizures