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Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures

This study is currently recruiting participants.
Verified November 2017 by Eisai Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02849626
First Posted: July 29, 2016
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
  Purpose
This is an open-label, multicenter study with an extension phase to evaluate the safety and tolerability of an perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to <12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic seizures (PGTC).

Condition Intervention Phase
Partial-Onset or Primary Generalized Tonic-Clonic Seizures Drug: Perampanel Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study With an Extension Phase to Evaluate the Safety, Tolerability, and Exposure Efficacy Relationship of Perampanel Oral Suspension When Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to Less Than 12 Years) With Inadequately Controlled Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Number of participants with any treatment-emergent adverse event (TEAE) and any serious adverse event (SAE) [ Time Frame: up to approximately 60 weeks ]

Secondary Outcome Measures:
  • Change in average seizure frequency over 28 days [ Time Frame: 28 days ]
  • Responder probability [ Time Frame: up to 27 weeks in the Treatment Period; up to 33 weeks in the Extension Phase ]
  • Number of participants who are seizure-free in the Maintenance Period of the Core Study [ Time Frame: 12 weeks ]
  • Change from Baseline in A-B neuropsychological assessment schedule (ABNAS) scores at Weeks 23 and 52 [ Time Frame: Baseline; Weeks 23 and 52 ]
  • Change from Baseline in Child Behavior Checklist (CBCL) scores at Weeks 23 and 52 [ Time Frame: Baseline; Weeks 23 and 52 ]
  • Change from Baseline in Lafayette Grooved Pegboard Test (LGPT) scores at Weeks 23 and 52 [ Time Frame: Baseline; Weeks 23 and 52 ]
  • Change from Baseline in height at Weeks 23 and 52 [ Time Frame: Baseline; Weeks 23 and 52 ]
  • Change from Baseline in weight at Weeks 23 and 52 [ Time Frame: Baseline; Weeks 23 and 52 ]
  • Change from Baseline in thyroid values at Weeks 23 and 52 [ Time Frame: Baseline; Weeks 23 and 52 ]
  • Change from Baseline in insulin-like growth factor-1 (IGF-1) values at Weeks 23 and 52 [ Time Frame: Baseline; Weeks 23 and 52 ]
  • Change from Baseline in electroencephalogram (EEG) values during awake and sleep states at Weeks 23 and 52 [ Time Frame: Baseline; Weeks 23 and 52 ]
  • Change from Baseline in the frequency of EEG abnormalities during awake and sleep states at Weeks 23 and 52 [ Time Frame: Baseline; Weeks 23 and 52 ]
  • Percentage of participants with any treatment-emergent reports of suicidal ideation and behavior assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: up to 27 weeks in the Treatment Period; up to 33 weeks in the Extension Phase ]
  • Percentage of participants with the indicated intensity of suicidal ideation and behaviors assessed using C-SSRS scores [ Time Frame: up to 27 weeks in the Treatment Period; up to 33 weeks in the Extension Phase ]
  • Median percent change in seizure frequency per 28 days during the Treatment Phase (Titration Period and Maintenance Period) of the Core Study, and during the long-term treatment (up to 52 weeks) relative to the Pretreatment Phase [ Time Frame: Week 4 of Pretreatment Phase, up to Week 27, up to Week 52 ]
  • Percentage of responders (25%, 50%, and 75% responders) during the Maintenance Period of the Core Study and during long-term treatment (up to 52 weeks) [ Time Frame: Week 12 and up to Week 52 ]
  • Percentage of participants who are seizure free during the Maintenance Period of the Core Study and during long-term treatment (up to 52 weeks) [ Time Frame: Week 12 and up to Week 52 ]
  • Change from Baseline in Clinical Global Impression scores [ Time Frame: Baseline; Weeks 23 and 52 ]

Estimated Enrollment: 160
Actual Study Start Date: November 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Perampanel
Perampanel 0.5 milligrams per milliliter (mg/mL) oral suspension
Drug: Perampanel
E2007

Detailed Description:
This is a multicenter, open-label, single-arm study in children (ages 4 to less than 12 years) with inadequately controlled POS or PGTC. The study will consist of a Core Study and Extension Phase. The Core Study will consist of the following 2 phases: Pretreatment and Treatment Phase. The Pretreatment Phase, during which participants will be assessed for eligibility, will consist of a 4-week Screening/Baseline Period. The Treatment Phase will consist of 3 periods: up to 11-week Titration Period (dose titration on the basis of individual clinical response and tolerability), 12-week Maintenance Period (continuation of perampanel oral suspension once daily at the dose level achieved at the end of the Titration Period), and 4-week Follow-up Period (only for those participants not rolling over into the Extension Phase). The Extension Phase will consist of a 29-week Maintenance Period and a 4-week Follow-up Period. All participants who complete all scheduled visits up to and including Visit 9 in the Treatment Phase will be eligible to participate in the Extension Phase of the study. During the Maintenance Period of the Extension Phase, all participants will continue with their optimal perampanel dose (i.e., dose level that they completed on during the Core Study). Participants who do not continue in the Extension Phase or those who prematurely discontinue from the study will enter a 4-week Follow-up Period.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of epilepsy with partial-onset seizures (POS) with or without secondarily generalized seizures or primary generalized tonic-clonic (PGTC) seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981). A diagnosis should have been established at least 6 months prior to Visit 1 by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e., clinical history)
  • Male or female participant, from age 4 to less than 12 years at the time of informed consent/assent
  • Have a minimum weight of 16 kilograms (kg) (35 pounds [lb])
  • Have had a brain imaging (e.g., magnetic resonance imaging [MRI] scan or computed tomography (CT)) before Visit 1 that ruled out a progressive cause of epilepsy
  • During the 12 weeks ± 3 days prior to Visit 2, participants must have had equal or greater than 1 POS or 1 PGTC seizure. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS
  • Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drug AEDs. Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a subject, the dose must be stable for at least 8 weeks prior to Visit 1. Only 1 EIAED (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 3 AEDs is allowed (A vagal nerve stimulator [VNS] will be counted as one of the 3 allowed AEDs.)

Exclusion Criteria:

  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin (β-hCG) (or human chorionic gonadotropin (hCG)) test with a minimum sensitivity of 25 International Units per liter (IU/L) or equivalent units of β-hCG or hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
  • Females of childbearing potential who:

    • Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. If a highly effective method is not appropriate or acceptable for the participant, then the participant may use a medically effective method (e.g., a double barrier method such as condom plus diaphragm with spermicide).
    • Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from being sexually active during the study period or for 28 days after study drug discontinuation.
    • Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation.
  • Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1.
  • Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1.
  • Have an unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified tests (e.g., significant suicide risk, including suicidal behavior and ideation within 6 months before Visit 1, current psychotic disorder, acute mania).
  • Any suicidal ideation with intent with or without a plan within 6 months before Visit 2 (i.e., answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)) in participants aged 6 and above.
  • Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented "failed" epilepsy surgery will be allowed.
  • 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 interfere with the study assessments.
  • Evidence of moderate or severe renal insufficiency as defined by estimated glomerular filtration rates (eGFRs) of 31 to < 60 "milliters per minute (mL/min)" and < 30 mL/min, respectively.
  • 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).
  • Evidence of significant active hematological disease; white blood cell (WBC) count equal or less than 2500/µL (2.50 1E+09/liter [L]) or an absolute neutrophil count equal or less than 1000/µL (1.00 1E+09/L).
  • Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than 450 milliseconds (msec).
  • Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  • Multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens Johnson syndrome), hematological, or organ toxicity reactions.
  • Concomitant use of felbamate as an AED for less than 2 years or where the dose has not been stable for at least 8 weeks before Visit 1. Participants must not have a history of WBC count equal to or less than 2500/µL, platelets below 100,000, liver function tests (LFTs) above 3 times the ULN, or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If participants received felbamate in the past, it must have been discontinued 8 weeks before Visit 1 to be eligible for study participation.
  • Concomitant use of vigabatrin: participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 and with documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in a visual perimetry test.
  • Concomitant use of cannabinoids
  • Used barbiturates (except for seizure control indication) within 4 weeks before Visit 1.
  • Used benzodiazepines (other than intermittent rescue use) for epilepsy (or for anxiety or sleep disorders) and for which the dose has not been stable for equal or greater than 4 weeks before Visit 1. Benzodiazepines use as rescue medication for seizure control is allowed; however, intermittent use of benzodiazepines for any other indication (eg, anxiety/sleep disorders) is prohibited.
  • A VNS implanted less than 5 months before Visit 1 or changes in parameter less than 4 weeks before Visit 1 (or thereafter during the study)
  • On a ketogenic diet for which the diet is not a stable regimen for at least 4 weeks before Visit 1.
  • History of or a concomitant medical condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study or compromise the participant's ability to safely complete the study.
  • Have previously been exposed to perampanel in a clinical trial or by prescription for more than 2 months or discontinued for Adverse Events (AEs).
  • 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.
  • Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849626


Contacts
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas For Medical Sciences Recruiting
Little Rock, Arkansas, United States
United States, California
Stanford University Recruiting
Palo Alto, California, United States
United States, Colorado
Colorado Children's Hospital Active, not recruiting
Aurora, Colorado, United States
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States
United States, Florida
NW FL Clinical Research Group, LLC Recruiting
Gulf Breeze, Florida, United States
Axcess Medical Research Recruiting
Loxahatchee Groves, Florida, United States
Pediatric Neurology PA Recruiting
Orlando, Florida, United States
United States, Georgia
Clinical Integrative Research Center of Atlanta Recruiting
Atlanta, Georgia, United States
Meridian Clinical Research Recruiting
Savannah, Georgia, United States
United States, Idaho
Consultants In Epilepsy and Neurology, PLLC Active, not recruiting
Boise, Idaho, United States
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States
Carle Foundation Hospital Active, not recruiting
Urbana, Illinois, United States
United States, Iowa
Mcfarland Clinic PC Recruiting
Ames, Iowa, United States
United States, Kansas
Via Christi Medical Associates Recruiting
Wichita, Kansas, United States
United States, Kentucky
Bluegrass Epilepsy Research LLC Active, not recruiting
Lexington, Kentucky, United States
University of Kentucky Recruiting
Lexington, Kentucky, United States
United States, Louisiana
Ochsner Baptist Medical Center Active, not recruiting
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center Not yet recruiting
Shreveport, Louisiana, United States
United States, Minnesota
Essentia Health - Duluth Clinic 3rd Street Building Active, not recruiting
Duluth, Minnesota, United States
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States
United States, Nevada
Clinical Research Center of Nevada Recruiting
Henderson, Nevada, United States
United States, New Jersey
Northeast Regional Epilepsy Group Active, not recruiting
Hackensack, New Jersey, United States
Clinical Research Center of New Jersey Active, not recruiting
Voorhees, New Jersey, United States
United States, New York
SUNY Downstate Medical Center Active, not recruiting
Brooklyn, New York, United States
United States, North Carolina
Wake Forest Baptist Medical Center Active, not recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Akron Children's Hospital Withdrawn
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States
United States, Tennessee
Le Bonheur Children's Hospital Outpatient Center - PIN Active, not recruiting
Memphis, Tennessee, United States
United States, Texas
Child Neurology Consultants of Austin Recruiting
Austin, Texas, United States
Road Runner Research Ltd Recruiting
San Antonio, Texas, United States
United States, Washington
MultiCare Institute for Research and Innovation Recruiting
Tacoma, Washington, United States
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Wauwatosa, Wisconsin, United States
Belgium
UZ Antwerpen Withdrawn
Pulderbos, Antwerpen, Belgium
Centre Neurologique William Lennox Recruiting
Ottignies, Brabant Wallon, Belgium
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Brussels, Belgium
Hopital Universitaire des Enfants Reine Fabiola Active, not recruiting
La Louviere, Hainaut, Belgium
UZ Brussel Active, not recruiting
Brussels, Belgium
France
Hopitaux de La Timone Recruiting
Marseille, Bouches-du-Rhone, France
CHRU Lille Recruiting
Lille Cedex, France
Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676 Recruiting
Paris, France
Hopitaux de Paris Recruiting
Paris, France
Hopitaux Universitaires de Strasbourg Active, not recruiting
Strasbourg, France
Centre Hospitalier Universitaire de Toulouse Recruiting
Toulouse Cedex 9, France
Hungary
Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza Recruiting
Budapest, Hungary
Servus Salvus Egeszsegugyi Szolgaltato Kft. Recruiting
Budapest, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz Recruiting
Miskolc, Hungary
Pecsi Tudomanyegyetem Recruiting
Pecs, Hungary
Italy
ASST di Mantova - Azienda Ospedaliera Carlo Poma Active, not recruiting
Mantova, Lombardia, Italy
IRCCS Fondazione Stella Maris Active, not recruiting
Calambrone, Toscana, Italy
Ospedale Bellaria Active, not recruiting
Bologna, Italy
Azienda Ospedaliera A Meyer Active, not recruiting
Firenze, Italy
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico Not yet recruiting
Milano, Italy
Japan
Hokkaido University Hospital Recruiting
Sapporo, Hokkaido, Japan
Shikoku Medical Center for Children and Adults Recruiting
Zentsuji, Kagawa, Japan
National University Corporation Tohoku University Tohoku University Hospital Active, not recruiting
Sendai-shi, Miyagi, Japan
Seirei Hamamtsu General Hospital Recruiting
Hamamatsu, Sizuoka, Japan
Fukuoka Children's Hospital Recruiting
Fukuoka-shi, Japan
Fukuoka University Hospital Recruiting
Fukuoka, Japan
Gifu Prefectural General Medical Center Recruiting
Gifu, Japan
Hakodate Central General Hospital Recruiting
Hakodate-shi, Japan
Hiroshima University Hospital Recruiting
Hiroshima, Japan
Osaka Women's and Children's Hospital Recruiting
Izumi, Japan
Shirasaka clinic Recruiting
Kobe, Japan
Kumamoto Ezuko Rehabilitation Medical Center Recruiting
Kumamoto, Japan
National Hospital Organization Nagoya Medical Center Active, not recruiting
Nagoya, Japan
Nara Medical Center Recruiting
Nara, Japan
National Hospital Organization Nishi-Niigata Chuo National Hospital Recruiting
Niigata, Japan
Okayama University Hospital Recruiting
Okayama, Japan
Nagasaki Medical Center Active, not recruiting
Omura, Japan
Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital Recruiting
Osaka, Japan
Kitasato University Hospital Recruiting
Sagamihara, Japan
Hokkaido Medical Center for Child Health and Rehabilitation Recruiting
Sapporo, Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders Recruiting
Shizuoka, Japan
Yamagata National Hospital Recruiting
Yamagata, Japan
Kanagawa Prefectural Hospital Organization Kanagawa Children's Medical Center Recruiting
Yokohama-shi, Japan
Korea, Republic of
Kyungpook National University Medical Center Active, not recruiting
Daegu, Korea, Republic of
Chungnam National University Hospital Active, not recruiting
Daejeon, Korea, Republic of
Gangnam Severance Hospital Active, not recruiting
Seoul, Korea, Republic of
Samsung Medical Center - PPDS Recruiting
Seoul, Korea, Republic of
Severance Hospital at Yonsei University Health System - PPDS Active, not recruiting
Seoul, Korea, Republic of
Latvia
Childrens University Hospital Recruiting
Riga, Latvia
Poland
Uniwersyteckie Centrum Kliniczne - PPDS Recruiting
Gdansk, Pomorskie, Poland
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki Recruiting
Kielce, Swietokrzyskie, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu Recruiting
Poznan, Wielkopolskie, Poland
Spain
Hospital Sant Joan de Deu - PIN Recruiting
Esplugues de Llobregat, Barcelona, Spain
Centro Medico Teknon - Grupo Quironsalud Recruiting
Barcelona, Spain
Hospital del Mar Recruiting
Barcelona, Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain
Hospital Universitari i Politecnic La Fe de Valencia Active, not recruiting
Valencia, Spain
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Eisai Medical Information Eisai Inc.
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02849626     History of Changes
Other Study ID Numbers: E2007-G000-311
First Submitted: July 26, 2016
First Posted: July 29, 2016
Last Update Posted: November 21, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Eisai Inc.:
Partial-Onset Seizures
Primary Generalized Tonic-Clonic Seizures
Adjunctive Therapy
Epilepsy

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms