Epilepsy
Conditions
Keywords
Epilepsy
Brief summary
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.
Detailed description
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.
Interventions
DRUGPerampanel
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment
Sponsors
Eisai Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent 2. Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit 3. Patients who provide informed consent
Exclusion criteria
1. Participation in another study involving administration of an investigational drug or device whilst participating in this observational study 2. Prior participation in a perampanel clinical study 3. Hypersensitivity to perampanel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) of interest | Up to 52 weeks and 2 weeks of follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of unintended pregnancy | Up to 52 weeks | — |
| Incidence of off-label use | Up to 52 weeks | — |
| Summary scores for the Hospital Anxiety and Depression Scale (HADS) | Screening, Week 52 | — |
| Number of TEAEs in the patient subpopulations of interest | Up to 52 weeks and 2 weeks of follow-up | 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. |
| Clinical Global Impression of Change | Week 52 | 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. |
Countries
Austria, Belgium, Czechia, Israel, Sweden, United Kingdom
Outcome results
None listed