部分発作（二次性全般発作の有無を問わず）または原発性全般強直間代発作を有する成人てんかん患者におけるフィコンパ錠の長期投与の臨床的安全性および有効性の調査

基本情報

NCT ID

NCT03059329

ステータス

完了

試験のフェーズ

-

試験タイプ

観察

目標被験者数

3,809

治験依頼者名

Eisai Inc.

概要

The objective of this study is to identify the following in adult 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).

対象疾患

介入

依頼者（Sponsor）