We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
July 26, 2016
July 29, 2016
November 21, 2017
November 2016
February 2018   (Final data collection date for primary outcome measure)
Number of participants with any treatment-emergent adverse event (TEAE) and any serious adverse event (SAE) [ Time Frame: up to approximately 60 weeks ]
Same as current
Complete list of historical versions of study NCT02849626 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures
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
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).
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Partial-Onset or Primary Generalized Tonic-Clonic Seizures
Drug: Perampanel
E2007
Experimental: Perampanel
Perampanel 0.5 milligrams per milliliter (mg/mL) oral suspension
Intervention: Drug: Perampanel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
October 2018
February 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
4 Years to 12 Years   (Child)
No
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com
Belgium,   France,   Hungary,   Italy,   Japan,   Korea, Republic of,   Latvia,   Poland,   Spain,   United States
 
 
NCT02849626
E2007-G000-311
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Eisai Medical Information Eisai Inc.
Eisai Inc.
November 2017

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