Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures — FYC01S  

Primary Generalized Tonic-clonic Seizures Clinical Trial

Official title: Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

Status Completed

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Epilepsy
• Neoplasm Metastasis
• Partial Seizures (With or Without Secondary Generalized Seizures)
• Primary Generalized Tonic-clonic Seizures
• Seizures

• NCT number: NCT03059329
• Study type: Observational
• Source: Eisai Inc.
• Status: Completed
• Start date: August 1, 2016
• Completion date: September 13, 2019