An observational study in Epilepsy, sponsored by Eisai Inc.. Completed at 42 sites in 6 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-09-07.
Sponsored by Eisai Inc. · Observational
The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.
This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 500 is above the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Epilepsy patients prescribed adjunctive treatment in countries where perampanel has received marketing approval. Multiple treating physicians will prescribe perampanel to patients, who then will be observed for approximately 52 weeks.
Exclusion Criteria
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment
Drug: Perampanel
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment
Number of Treatment Emergent Adverse Events (TEAEs) of interest
Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.
Time frame: Up to 52 weeks and 2 weeks of follow-up
Incidence of unintended pregnancy
Time frame: Up to 52 weeks
Incidence of off-label use
Time frame: Up to 52 weeks
Summary scores for the Hospital Anxiety and Depression Scale (HADS)
Time frame: Screening, Week 52
Number of TEAEs in the patient subpopulations of interest
TEAEs observed in the specified subpopulations of patients could also be made in order to get a better understanding of whether any of these particular potential risk factors (e.g., old age, cardiovascular disease) define groups with greater or lesser risk.
Time frame: Up to 52 weeks and 2 weeks of follow-up
Clinical Global Impression of Change
Assessment of disease severity will utilize the Clinical Global Impression of Change (CGI-C) scale at end of treatment to evaluate change in disease status since initiation of treatment.
Time frame: Week 52
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Eisai Inc.