EUCTR2010-018518-56-HUActive, not recruitingNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Eisai Limited
- Enrollment
- 132
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Core Study:
- •- 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
- •- Understand the requirements of the CDR System tests and able to perform the tests appropriately at Visit 1
- •- Male or female, 12 to less than 18 years of age at the time of consent/assent
- •- 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). Diagnosis should have been established at least 6 months prior to Visit 1, by clinical history and an 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)
- •- Have had a brain imaging (eg, 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
- •- 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 AEDs
- •- 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
- •- 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
- •- Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (ß-hCG) at Visit 1 and a negative urine pregnancy test prior to randomization 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 medication to commit to the consistent and correct use of a medically acceptable method of birth control (eg, 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
- •- 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 132
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •- With a diagnosis of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
- •- Have current or a history of pseudo-seizures (psychogenic non-epileptic seizures [PNES]) within approximately 5 years prior to Visit 1
- •- Have a diagnosis of Lennox-Gastaut syndrome
- •- Have seizure clusters where individual seizures cannot be counted
- •- Have a history of status epilepticus that required hospitalization during the 12 months prior to the Visit 1
- •- 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 (eg, significant suicide risk, including suicidal behavior and ideation 6 months prior to Visit 1, current psychotic disorder, or acute mania)
- •- Have any concomitant illnesses/co-morbidities (eg, autism, attention-deficit hyperactivity disorder [ADHD]) at Visit 1 that could severely affect cognitive function during the course of the study
- •- Have previously participated in a clinical trial involving perampanel
- •- Have chronically or routinely use benzodiazepines and who have not discontinued use at least 4 weeks prior to Visit 1
- •Extension phase
- •- Those who, for any reason, discontinued early from the preceding double-blind study
Investigators
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