Partial Seizures (With or Without Secondary Generalized Seizures), Primary Generalized Tonic-clonic Seizures
Conditions
Keywords
adolescent epilepsy participants, partial seizures, primary generalized Tonic-clonic seizures
Brief summary
The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa: 1. unknown adverse drug reactions (ADRs); 2. occurrence of ADRs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
Interventions
DRUGFycompa
The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.
Sponsors
Eisai Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Epilepsy participants from 12 to 17 years of age with: * Partial seizures (with or without secondary generalized seizures) * Primary generalized Tonic-clonic seizures
Exclusion criteria
* Participants previously treated with Fycompa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with any serious adverse event | from 0 to 104 weeks |
| Number of participants with any non-serious adverse event | from 0 to 104 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants experiencing seizures | from 0 to 104 weeks |
| Overall improvement rating in seizure frequency | from 0 to 104 weeks |
Countries
Japan
Outcome results
None listed