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Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures

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ClinicalTrials.gov Identifier: NCT03288129
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

September 13, 2017
September 19, 2017
September 7, 2018
August 23, 2017
June 3, 2020   (Final data collection date for primary outcome measure)
  • Number of participants remaining on perampanel at 3 months after the initiation of treatment (retention rate) [ Time Frame: Month 3 ]
    The retention rate is defined as the number of participants remaining on perampanel treatment at 3 months after the initiation of treatment.
  • Number of participants remaining on perampanel at 6 months after the initiation of treatment (retention rate) [ Time Frame: Month 6 ]
    The retention rate is defined as the number of participants remaining on perampanel treatment at 6 months after the initiation of treatment.
  • Number of participants remaining on perampanel at 9 months after the initiation of treatment (retention rate) [ Time Frame: Month 9 ]
    The retention rate is defined as the number of participants remaining on perampanel treatment at 9 months after the initiation of treatment.
  • Number of participants remaining on perampanel at 12 months after the initiation of treatment (retention rate) [ Time Frame: Month 12 ]
    The retention rate is defined as the number of participants remaining on perampanel treatment at 12 months after the initiation of treatment.
Same as current
Complete list of historical versions of study NCT03288129 on ClinicalTrials.gov Archive Site
  • Number of participants who achieve seizure-free status for partial-onset seizures (POSs), secondarily generalized (SG) seizures, and primary generalized tonic-clonic (PGTC) seizures during the Maintenance Period [ Time Frame: Up to 39 weeks ]
    Seizure frequency data will be collected in participant diaries by participants or by the guardian/legally authorized representative, and the data will be reviewed by the investigators. Seizure-free status is defined as no incidence of seizure. Partial seizures occur when abnormal electrical activity begins in only one part of the brain and include (1) simple partial seizures, where a participant does not lose consciousness and may experience muscle jerking or stiffening, and (2) complex partial seizures, where a participant loses awareness. SG seizures are disturbances that spread to both sides of the brain after a partial seizure has already begun and happen when a burst of electrical activity in a limited area (the partial seizure) spreads throughout the brain. PGTC seizures are disturbances in the functioning of both sides of the brain that are caused by electrical signals spreading through the brain inappropriately.
  • Number of participants who achieve 3-month seizure-free status for POS, SG, and PGTC [ Time Frame: Up to Month 3 ]
    Seizure frequency data will be collected in participant diaries by participants or by the guardian/legally authorized representative, and the data will be reviewed by the investigators. Seizure-free status is defined as no incidence of seizure. Partial seizures occur when abnormal electrical activity begins in only one part of the brain and include (1) simple partial seizures, where a participant does not lose consciousness and may experience muscle jerking or stiffening, and (2) complex partial seizures, where a participant loses awareness. SG seizures are disturbances that spread to both sides of the brain after a partial seizure has already begun and happen when a burst of electrical activity in a limited area (the partial seizure) spreads throughout the brain. PGTC seizures are disturbances in the functioning of both sides of the brain that are caused by electrical signals spreading through the brain inappropriately.
  • Number of participants who achieve 6-month seizure-free status for POS, SG, and PGTC [ Time Frame: Up to Month 6 ]
    Seizure frequency data will be collected in participant diaries by participants or by the guardian/legally authorized representative, and the data will be reviewed by the investigators. Seizure-free status is defined as no incidence of seizure. Partial seizures occur when abnormal electrical activity begins in only one part of the brain and include (1) simple partial seizures, where a participant does not lose consciousness and may experience muscle jerking or stiffening, and (2) complex partial seizures, where a participant loses awareness. SG seizures are disturbances that spread to both sides of the brain after a partial seizure has already begun and happen when a burst of electrical activity in a limited area (the partial seizure) spreads throughout the brain. PGTC seizures are disturbances in the functioning of both sides of the brain that are caused by electrical signals spreading through the brain inappropriately.
  • Number of participants who receive perampanel as a first adjunctive therapy who are able to convert to perampanel monotherapy [ Time Frame: Up to 39 weeks ]
    The number of participants who receive perampanel as a first adjunctive therapy who are able to convert to perampanel monotherapy will be reported.
  • Number of participants with any treatment-emergent adverse event (AE) [ Time Frame: Up to approximately 24 months ]
    An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. A treatment-emergent AE is defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
  • Number of participants with any treatment-emergent serious adverse event (SAE) [ Time Frame: Up to approximately 24 months ]
    An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A treatment-emergent AE is defined as an event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier than 6 weeks before the first dose of study drug), a Titration Period (13 weeks), a Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Partial Onset Seizures
  • Secondarily Generalized Seizures
  • Primary Generalized Tonic-Clonic Seizures
Drug: Perampanel
film-coated tablets
Other Names:
  • Fycompa
  • E2007
Experimental: Perampanel
Perampanel will be administered orally once daily (QD) at bedtime. At the beginning of the Titration Period, oral perampanel will start at a dose of 2 milligrams (mg) QD. Doses of perampanel will then be up titrated in increments of 2 mg/day at no less than 2-week intervals according to the investigator's judgment. At the 4 mg dose, the investigator will confirm whether further dose escalation is needed based on participant response and tolerability. The investigator may adjust dosing further or leave the participant at 4 mg. The maximum dose is 12 mg. During the 39-week Maintenance Period, participants will continue to receive the perampanel dose level that was administered at the end of the Titration Period.
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
300
Same as current
June 3, 2020
June 3, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants will be male or female and no younger than 12 years of age.
  • Participants must have a diagnosis of epilepsy with partial-onset seizures (POS) (with or without secondarily generalized seizures [SG]) or with primary generalized tonic clonic seizures (PGTC) according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981).
  • Participants who receive perampanel as a first adjunctive therapy must currently have been treated with stable doses of monotherapy for 8 weeks prior to Visit 2 (Week 0), have not previously received adjunctive anti-epileptic drug (AED) treatment, and must, in the investigator's judgement, be in need of initial adjunctive therapy after failure to control seizures with AED monotherapy, at the optimal dose and duration.
  • Participants who receive perampanel as monotherapy, who were newly diagnosed (treatment naïve), must have experienced 2 or more well documented seizures within the past year, with at least 24 hours between these seizures.
  • Participants who are currently receiving monotherapy treatment may receive perampanel as monotherapy if, in the investigator's judgment, the participant may benefit from a change in monotherapy treatment. Participants must not have previously received adjunctive AED treatment.
  • If antidepressants or antianxiety drugs are used, participants must be on a stable dose regimen of these drugs during the 8 weeks before Visit 2 (Week 0).

Exclusion Criteria:

  • Participants should not have previously received or currently be receiving perampanel.
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic gonadotropin [β-hCG] or 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:

    • Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:

      • Total abstinence (if it is their preferred and usual lifestyle)
      • An intrauterine device or intrauterine hormone-releasing system
      • An oral contraceptive (with additional barrier method if using contraceptive containing levogesterol); participant must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation
      • Have a vasectomized partner with confirmed azoospermia
    • Do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation For sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, ie, double barrier methods of contraception such as condom plus diaphragm or cervical/vault cap with spermicide.

NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).

  • Presence of or previous history of Lennox-Gastaut syndrome
  • Presence of non-motor simple partial seizures only
  • A history of status epilepticus within 1 year before Screening Visit (Visit 1)
  • Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Screening Visit (Visit 1)
  • Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
  • Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 2 (Week 0)
  • Use of intermittent rescue benzodiazepines (ie, 1 to 2 doses over a 24-hour period is considered a one time rescue) 2 or more times in the 8-week period prior to Visit 2 (Week 0)
  • Severe renal insufficiency (defined by estimated glomerular filtration rate of < 30 milliliters per minute [mL/min]) or participants who receive hemodialysis
  • Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the participant's safety or study conduct NOTE: Stable elevation of liver enzymes, alanine aminotransferase and aspartate aminotransferase due to concomitant medication(s) will be allowed if they are less than 3 times the upper limits of normal.
  • Hypersensitivity to perampanel or any excipients
  • Participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
  • Participants who are participating in other interventional clinical trial
  • Participant who are judged to have inadequate cognitive ability for participation in the study (intelligence quotient < 80 or investigator judgment)
  • Any suicidal ideation with intent with or without a plan, at the time of or within 6 months of screening, as indicated by answering "Yes" to questions 4 and 5 on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS)
  • Any lifetime suicidal behavior based on the C-SSRS
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
No
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com
United States
 
 
NCT03288129
E2007-G000-410
2017-001180-20 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Principal Investigator: Pavel Klein Mid-Atlantic Epilepsy and Sleep Center
Eisai Inc.
November 2017

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