Clinical Trial Details

NCT ID: NCT02914314
Date Last Changed: September 11, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating perampanel for the treatment of Epilepsy

Research Study Title

An Open-Label Study With an Extension Phase to Evaluate the Pharmacokinetics of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Subjects From 1 Month to Less Than 24 Months (<2 Years) of Age With Epilepsy

Purpose

The purpose of this study is to evaluate the pharmacokinetics (PK) of an oral suspension of perampanel given as an adjunctive therapy and to generate preliminary safety and efficacy data in pediatric participants, ranging from 1 month to less than 24 months of age, with epilepsy.

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Recruitment Details

Phase
2
Gender
All
Age
1 to 24 Months
Overall Status
Recruiting
Lead Sponsor
Eisai Inc.
Duration
18 Months
Facility Type
N/A
Compensation

Eligibility

All ages 1 Month to 24 Months

Inclusion Criteria:

  • Male or female, from 1 to less than 24 months ( < 2 years) of age (and of at least 36 weeks gestational age) at the time of consent

  • Have a minimum weight of 4 kilograms (kg) (8.8 pounds [lb])

  • Have a diagnosis of epilepsy with any type of seizure according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 2 weeks (≤6 months of age) or 4 weeks ( > 6 months of age) before Visit 1, by clinical history and an electroencephalogram (EEG) that is consistent with epilepsy; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e., clinical history)

  • Have had brain imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) before Visit 1 that ruled out a progressive cause of epilepsy

  • Have had 1 or more seizure(s) before Visit 1

  • Currently being treated with a stable dose (i.e., unchanged for at least 5 half-lives) of 1 to a maximum of 3 antiepileptic drugs (AEDs) (at least 6, but not more than 8, participants will be taking 1 enzyme-inducing AED [EIAEDs] out of the maximum of 3 AEDs allowed. The remaining participants cannot be taking any EIAEDs).

  • Have been on their current concomitant AED regime with a stable dose for at least 2 weeks (≤6 months of age) or 4 weeks ( > 6 months of age) before Visit 1

  • Must have discontinued all restricted medications at least 2 weeks or 5 half-lives (whichever is longer) before Visit 1

  • If entering the Extension Phase, must have completed the last visit of the Maintenance Period of the Core Study

Exclusion Criteria:

  • Have a history of status epilepticus that required hospitalization during the 3 months before Visit 1

  • Have seizures due to treatable medical conditions, such as those arising due to metabolic disturbances, toxic exposure, or an active infection

  • Have epilepsy secondary to progressive central nervous system (CNS) disease or any other progressive neurodegenerative disease, including tumors

  • Have had epilepsy surgery within 1 year of Visit 1

  • Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1

  • Used intermittent rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period considered one-time rescue) 2 or more times in the 2 weeks before Visit 1

  • Prior use of felbamate

  • Prior use of vigabatrin

  • Are on ketogenic diet regimen that has not been stable for at least 4 weeks before Visit 1

  • Have used other drugs known to influence the CNS, where the dose has not been stabilized for at least 2 weeks (≤6 months of age) or 4 weeks ( > 6 months of age) before Visit 1

  • Have any concomitant illnesses/co-morbidities that could severely affect the participant's safety or study conduct

  • Have evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or study conduct

  • Have clinically significant laboratory abnormalities or any clinically acute or chronic disease

  • Have evidence of significant active hepatic disease. Stable elevation of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) due to concomitant medication(s), will be allowed if they are less than 3 times the upper limit of normal (ULN)

  • Have clinical evidence of significant active hematological disease; white blood cell (WBC) count ≤2500/ microliter (μL) (2.50 x 10^9/Liter [L]) or an absolute neutrophil count ≤1000/μL (1.00 x 10^9/L)

  • Have conditions that may interfere with their participation in the study and/or with the PK of study drug

  • Have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer

  • Have previously participated in a clinical trial involving perampanel

  • Have a clinically significant ECG abnormality, including prolonged corrected QT interval (QTc) defined as > 450 milliseconds (msec)

  • Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions

Site Locations (12)

Country State City Zip Facility and Contact
United States California Los Angeles 90027 Children's Hospital Los Angeles
United States Florida Gulf Breeze 32561 NW FL Clinical Research Group, LLC
United States Florida Loxahatchee Groves 33470 Pediatric Neurologists of Palm Beach
United States Florida Orlando 32819 Pediatric Neurology PA
United States Florida Tampa 33609 Pediatric Epilepsy and Neurology Specialists
United States Illinois Urbana 61801 Carle Foundation Hospital
United States Kentucky Lexington 40536-0284 University of Kentucky
United States Missouri Kansas City 64108-4619 Children's Mercy Hospital
United States North Carolina Winston-Salem 27157 Wake Forest Baptist Medical Center
United States Texas Austin 78731 Child Neurology Consultants of Austin
United States Texas San Antonio 78258 Road Runner Research Ltd
Latvia Riga Childrens University Hospital

Contact

Eisai Medical Information
1-888-274-2378
E-mail:

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