A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents - NCT01161524-(Clinical Trial 702171)
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Norfolk, |
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State:
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VA |
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| Conditions: |
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Epilepsy |
| Purpose: |
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This study is designed to investigate the short- and long-term effects of perampanel on
cognition, growth, and development in adolescents.
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| Study summary: |
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| Criteria: |
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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 (β-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 |
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| Study is available at: |
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*
Norfolk,, VA
United States
Primary Contact:
* Eisai Medical Services
Phone: 1-888-422-4743 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
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