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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


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Recruiting NCT05667142 - A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures Phase 3
Completed NCT03288129 - Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures Phase 4
Completed NCT03059381 - Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Completed NCT02736162 - Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With Epilepsy N/A