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).
Study Type
OBSERVATIONAL
Enrollment
519
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.
Unnamed facility
Osaka, Japan
Unnamed facility
Tokyo, Japan
Number of participants with any serious adverse event
Time frame: from 0 to 104 weeks
Number of participants with any non-serious adverse event
Time frame: from 0 to 104 weeks
Number of participants experiencing seizures
Time frame: from 0 to 104 weeks
Overall improvement rating in seizure frequency
Time frame: from 0 to 104 weeks
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