A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents

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. Read our disclaimer for details. Identifier: NCT01161524
Recruitment Status : Unknown
Verified February 2014 by Eisai Inc..
Recruitment status was:  Active, not recruiting
First Posted : July 13, 2010
Last Update Posted : February 27, 2014
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
This study is designed to investigate the short- and long-term effects of perampanel on cognition, growth, and development in adolescents.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Perampanel Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an Adjunctive Therapy in Adolescents (12 to Less Than 18 Years of Age) With Inadequately Controlled Partial-onset Seizures
Study Start Date : October 2010
Actual Primary Completion Date : July 2013
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Perampanel

Arm Intervention/treatment
Experimental: 1 Drug: Perampanel
2 mg titrated up to 8-12mg maximum; taken once daily

Placebo Comparator: 2 Drug: Placebo
Matching Placebo taken once daily.

Primary Outcome Measures :
  1. Change from baseline in the Cognitive Drug Research (CDR) System Global Cognition Score. [ Time Frame: Baseline, 52 weeks ]
    Cognitive Drug Research (CDR) System Global Cognition Score also called the following factor scores: Power of Attention, Continuity of Attention, Quality of Episodic Memory, Quality of Working Memory, and Speed of Memory.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Considered reliable and willing to be available for the study duration and is able to record seizures and report adverse events (AEs) themselves or have a legal guardian or a caregiver who can record seizures and report AEs for them
  2. Understand the requirements of the Cognitive Drug Research (CDR) System tests and able to perform the tests appropriately at Visit 1
  3. Male or female, 12 to less than 18 years of age at the time of consent/assent
  4. Have a diagnosis of epilepsy with partial-onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981).
  5. Diagnosis should have been established at least 6 months prior to Visit 1, by clinical history and an electroencephalogram (EEG) that is consistent with localization-related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
  6. Have had a brain imaging (e.g., magnetic resonance imaging [MRI] scan or computed tomography[CT]) within the 5 years prior to Visit 1 that ruled out a progressive cause of epilepsy
  7. Must have had at least 1 partial-onset seizure during the 4 weeks prior to Visit 1 despite a stable regimen of 1 to 3 concomitant antiepileptic drugs (AEDs)
  8. Are currently being treated with stable doses of 1-3 AEDs. Only 1 inducer AED (either carbamazepine or phenytoin) out of the maximum of 3 AEDs is allowed
  9. Are on a stable dose of the same concomitant AED(s) for at least 4 weeks prior 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
  10. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (?-hCG) at Visit 1 and a negative urine pregnancy test prior to randomization at Visit 2. Female subjects of period of at least 60 days following administration of the last dose of study medication to 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]). Abstinence will be considered an acceptable method of contraception on a case by case basis upon prior approval by the Medical Monitor
  11. Have an intelligence quotient (IQ) of ?70, using the Kaufman Brief Intelligence Test, second edition (KBIT-2)

Extension Phase:

Have completed all scheduled visits up to and including Visit 8 in the Core Study Randomization Phase

Exclusion Criteria:

  1. Have a diagnosis of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
  2. Have current or a history of pseudo-seizures (psychogenic non-epileptic seizures [PNES]) within approximately 5 years prior to Visit 1
  3. Have a diagnosis of Lennox-Gastaut syndrome
  4. Have seizure clusters where individual seizures cannot be counted
  5. Have a history of status epilepticus that required hospitalization during the 12 months prior to the Visit 1
  6. Have an unstable psychiatric diagnosis that may confound the investigator's ability to conduct the study or that may prevent completion of the protocol specified tests (e.g., significant suicide risk, including suicidal behavior and ideation 6 months prior to Visit 1, current psychotic disorder, or acute mania)
  7. Have any concomitant illnesses/co-morbidities (e.g., autism, attention deficit hyperactivity disorder [ADHD]) at Visit 1 that could severely affect cognitive function during the course of the study
  8. Have previously participated in a clinical trial involving perampanel
  9. Have chronically or routinely use benzodiazepines and who have not discontinued use at least 4 weeks prior to Visit 1

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 identifier (NCT number): NCT01161524

United States, Colorado
Denver, Colorado, United States
United States, Florida
Eisai Medical Services
Gulf Breeze, Florida, United States, 32561
Eisai Medical Services
Orlando, Florida, United States, 32835
Pensacola, Florida, United States
Tampa, Florida, United States
United States, Missouri
Chesterfield, Missouri, United States
Columbia, Missouri, United States
United States, New Jersey
Eisai Medical Services
Voorhees, New Jersey, United States, 8043
United States, Virginia
Norfold, Virginia, United States
Sponsors and Collaborators
Eisai Inc.
Study Director: Haichen Yang, M.D., M.A. Study Director

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eisai Inc. Identifier: NCT01161524     History of Changes
Other Study ID Numbers: E2007-G000-235
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014