Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01527006
First received: November 10, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric subjects maintained on one to three stable antiepileptic drugs


Condition Intervention Phase
Central Nervous System
Drug: perampanel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Pilot Study With an Extension Phase to Evaluate the Pharmacokinetics, and to Generate Preliminary Safety, Tolerability, and Efficacy of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Pediatric Subjects From 2 to Less Than 12 Years of Age With Epilepsy

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • The effect of demographics on population PK parameters AUC [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • The effect of demographics on population PK parameters Cmax [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • The effect of demographics on population PK parameters tmax [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • The effect of the most common concomitant AEDs on population PK parameters AUC [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • The effect of the most common concomitant AEDs on population PK parameters Cmax [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
  • The effect of the most common concomitant AEDs on population PK parameters tmax [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Adverse Event [ Time Frame: from Baseline through week 52 ] [ Designated as safety issue: Yes ]
  • Seizure frequency per 28 days [ Time Frame: change from baseline to week 11 and 52 ] [ Designated as safety issue: No ]
  • Responder Rate [ Time Frame: change from baseline to week 11 and 52 ] [ Designated as safety issue: No ]
  • Seizure-free Status [ Time Frame: change from baseline to week 11 and 52 ] [ Designated as safety issue: No ]
  • Global Clinical Impression [ Time Frame: change from baseline to weeks 11, 28 and 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: February 2012
Estimated Study Completion Date: April 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: perampanel Drug: perampanel
perampanel 0.015 mg/kg/day up-titrated up to a maximum of 0.18 mg/kg/day taken once daily Perampanel: up to 0.18mg/kg, oral suspension, once daily; age Cohort 1 (>=7 to less than 12 years of age at time of consent/assent) and age Cohort 2 (>=2 to less than 7 years of age)

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Have a minimum weight of 10 kg (22 lb)
  2. Have had brain imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) prior to Visit 1 that ruled out a progressive cause of epilepsy
  3. 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 6 months prior to Visit 1, by clinical history and an electroencephalogram (EEG) that is consistent with epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (i.e., clinical history)
  4. Have had one or more seizure(s) during the 4 weeks prior to Visit 1
  5. Are currently being treated with stable doses of one to a maximum of three AEDs for at least 4 weeks prior to Visit 1 and throughout the study duration (Only one perampanel inducing AED [i.e., carbamazepine, oxcarbazepine, phenytoin] out of the maximum of 3 AEDs is allowed in at least one third of the subjects in each age cohort and not to exceed one half of the population of each age cohort. The remaining subjects should not be taking any inducer)
  6. Have been on their current concomitant AED regimen for 2 months or more with a stable dose for at least 4 weeks prior to Visit 1
  7. Must have discontinued all restricted medications at least 2 weeks or five half-lives (whichever is longer) prior to Visit 1
  8. Females aged at least 8 years or of child-bearing potential must have a negative serum B-hCG at Visit 1 and a negative urine pregnancy test prior to titration at Visit 2. Female subjects of childbearing potential must agree for the duration of the study and for a period of at least 60 days following administration of the last dose of study drug to be abstinent or commit to the consistent and correct use of a medically acceptable method of birth control (e.g., a double-barrier method [condom + spermicide, condom + diaphragm with spermicide])

Exclusion:

  1. Have a history of status epilepticus that required hospitalization during the 6 months prior to Visit 1
  2. Have current or a history of pseudo-seizures (psychogenic non-epileptic seizures [PNES]) from birth or within approximately 5 years prior to Visit 1
  3. Have seizures due to treatable medical conditions, such as those arising due to metabolic disturbances, toxic exposure, or an active infection
  4. Have epilepsy secondary to progressive cerebral disease or any other progressive neurodegenerative disease
  5. Have had epilepsy surgery within 1 year prior to Visit 1
  6. 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
  7. Use of intermittent rescue benzodiazepines (i.e., 1-2 doses over a 24-hour period considered one-time rescue) two or more times in a 30-day period prior to Visit 1
  8. If felbamate is used as a concomitant AED, subjects must be on felbamate for at least 2 years, with a stable dose for 8 weeks prior to Visit 1. They must not have a history of white blood cell (WBC) count below 2500/L (2.50 x 109/L), platelets below 100,000, liver function tests (LFTs) above 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If subjects received felbamate in the past, it must have been discontinued 8 weeks prior to Visit 1
  9. Have concomitant use of vigabatrin: subjects who took vigabatrin in the past must be off vigabatrin for approximately 5 months prior to Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in the visual perimetry test
  10. If ketogenic diet is used, subjects must be on a stable regimen for at least 4 weeks prior to Visit 1
  11. Have previously participated in a clinical trial involving perampanel
  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: NCT01527006

  Show 20 Study Locations
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Michelle Gee Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01527006     History of Changes
Other Study ID Numbers: E2007-G000-232
Study First Received: November 10, 2011
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014