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Trial record 12 of 62 for:    perampanel

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT02849626
First received: July 26, 2016
Last updated: October 17, 2016
Last verified: October 2016
  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: 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
Study Start Date: October 2016
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: September 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

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 4 weeks before Visit 2, participants must have had equal or greater than one POS or one PGTC seizure. Only a simple POS with motor signs, a complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS.
  • Are currently being treated with stable doses of one to a maximum of two approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before Visit 1; in the case in which a new AED regimen has been initiated for a participant, the dose must be stable for at least 8 weeks before Visit 1. Only one enzyme-inducing AED (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of two AEDs is allowed (a vagal nerve stimulator (VNS) will be counted as one of the two 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.
  • Severe renal insufficiency
  • 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.
  • 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.
  • 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 the administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately five half-lives of the previous investigational compound, whichever is longer.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02849626

Contacts
Contact: Eisai Medical Information 1-888-274-2378

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
Study First Received: July 26, 2016
Last Updated: October 17, 2016

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

ClinicalTrials.gov processed this record on April 26, 2017