Health Condition 1: G408- Other epilepsy and recurrent seizures
Conditions
Interventions
Intervention1: Perampanel: Single daily dose administration of perampanel given as multiple oral 2-mg tablets to give a dose of 2 mg/day to 8 mg/day (randomization phase) or up to 12 mg/day (Extension
Sponsors
Eisai Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have diagnosis of Lennox-Gastaut Syndrome (LGS) 2. At least 2 years old at the time of consent/assent 3. Age of LGS onset must be 4. Must have an average of at least 2 drop seizures per week in the 4-week Baseline Period 5. Must be taking 1 to 4 concomitant anti-epileptic drugs (AEDs) at a stable dose for at least 30 days before Visit 1
Exclusion criteria
Exclusion criteria: 1. Presence of progressive neurological disease 2. Presence of drop seizure clusters where individual seizures cannot be reliably counted 3. Prior treatment with perampanel with discontinuation due to safety issues related to perampanel or recent treatment with perampanel within 30 days before Screening 4. Scheduled for epilepsy-related surgery or other surgery during the study 5. Status epilepticus within 12 weeks before Screening 6. Current use of felbamate of less than 1 year, or with dose changes within 60 days before Screening, or history of hematological/hepatic function test abnormalities or other indication of hepatic/bone marrow dysfunction while receiving felbamate. 7. Current or recent use of vigabatrin within 5 months of Screening, or history of vigabatrin-associated clinically significant abnormality in an automated visual perimetry test 8. Intermittent use of benzodiazepine of more than 4 single administrations in the month before Screening 9. Psychotic disorders or unstable recurrent affective disorders evident by use of antipsychotics or prior suicide attempts within approximately the last 2 years 10. Use of AEDs not recommended by Epilepsy Treatment Guidelines for use in LGS 11. Any suicidal ideation with intent with or without a plan within 6 months before Randomization Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that perampanel given as adjunctive antiepileptic treatment is superior to placebo in reducing the incidence of drop seizures in subjects with inadequately controlled seizures associated with LGSTimepoint: Median percent change in drop seizure frequency per 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate that perampanel adjunctive treatment is superior to placebo in reducing the incidence of all seizures in subjects with inadequately controlled seizures associated with LGSTimepoint: Median percent change in total seizure frequency per 28 days;To demonstrate that perampanel adjunctive treatment is superior to placebo in reducing the incidence of non-drop seizures in subjects with inadequately controlled seizures associated with LGSTimepoint: Median percent change in non-drop seizure frequency per 28 days;To demonstrate that perampanel adjunctive treatment is superior to placebo in the 50%, 75%, and 100% responder rates for drop seizures in subjects with inadequately controlled seizures associated with LGSTimepoint: 50% responder rate for drop seizures Others: 75% and 100% responder rates for drop seizures ;To demonstrate that perampanel adjunctive treatment is superior to placebo in the 50%, 75%, and 100% responder rates for total seizures in subjects with inadequately controlled seizures associated with LGSTimepoint: 50% responder rate for total seizures Others: 75% and 100% responder rates for total seizures ;To evaluate physicians’ global evaluation of subjects’ overall changes in symptoms Physicians’ global evaluation of the subject’s overall changes in symptomsTimepoint: Physicians’ global evaluation of the subject’s overall changes in symptoms;To evaluate the 50%, 75%, and 100% responder rates in non-drop seizure frequencyTimepoint: 50%, 75%, and 100% responder rates for non-drop seizures;To evaluate the pharmacokinetics (PK) and the pharmacokinetic/pharmacodynamic (PK/PD) relationships of perampanel as adjunctive therapy in subjects with inadequately controlled seizures associated with LGSTimepoint: Model-derived average perampanel concentrations at steady state (Cav,ss);To evaluate the safety of perampanel relative to placebo as adjunctive therapy in subjects with inadequately controlled seizures associated with LGSTimepoint: Incidence of A | — |
Countries
Australia, Belgium, Czech Republic, India, Japan, Republic of Korea, United States of America
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
Outcome results
None listed