An observational study in Refractory Epilepsy, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 16 Years to 86 Years. Per ClinicalTrials.gov, last updated 2016-08-24.
Sponsored by Hospices Civils de Lyon · Observational
Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy.
The investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).
261 studies on the registry are indexed under Drug Resistant Epilepsy; 99 are open to participants now.
This study's enrollment of 110 is above the median of 88 across 40 observational studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with refractory focal epilepsy in which Perampanel were introduced between May 2014 and April 2015
Exclusion Criteria:
Drug: Perampanel
Retention rate
Proportion of patient still treated with Perampanel 6 months after its initiation
Time frame: 6 months
Retention rate
Proportion of patients still treated with Perampanel 12 months after its initiation
Time frame: 12 months
Seizure freedom
Proportion of seizure-free patients during at least 6 months
Time frame: 6 months
Responder rates
Responder rates is defined as a reduction in seizure frequency of 50% or more compared with the three months before the initiation of perampanel.
Time frame: 6 months
Responder rates
Responder rates is defined as a reduction in seizure frequency of 50% or more compared with the three months before the initiation of perampanel.
Time frame: 12 months
Total withdrawal rate
Discontinuation rates at 6 months due to inefficiency or adverse effects
Time frame: 6 months
Total withdrawal rate
Discontinuation rates at 12 months due to inefficiency or adverse effects
Time frame: 12 months
Observed adverse effects during the observation period
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon