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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01161524
First received: July 12, 2010
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Epilepsy
Drug: Perampanel
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Change from baseline in the Cognitive Drug Research (CDR) System Global Cognition Score. [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 133
Study Start Date: October 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01161524

Locations
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.
Investigators
Study Director: Haichen Yang, M.D., M.A. Study Director
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01161524     History of Changes
Other Study ID Numbers: E2007-G000-235
Study First Received: July 12, 2010
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 16, 2014