Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)
- Registration Number
- NCT02876289
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- Patients with refractory focal epilepsy
- Initiation of perampanel between 05/2014 and 04/2015
- Exact date of initiation of Perampanel not defined
- Patients without follow-up data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients treated with Perampanel Perampanel -
- Primary Outcome Measures
Name Time Method Retention rate 6 months Proportion of patient still treated with Perampanel 6 months after its initiation
- Secondary Outcome Measures
Name Time Method Retention rate 12 months Proportion of patients still treated with Perampanel 12 months after its initiation
Total withdrawal rate 12 months Discontinuation rates at 12 months due to inefficiency or adverse effects
Observed adverse effects during the observation period 12 months Seizure freedom 6 months Proportion of seizure-free patients during at least 6 months
Responder rates 12 months Responder rates is defined as a reduction in seizure frequency of 50% or more compared with the three months before the initiation of perampanel.
Trial Locations
- Locations (1)
Hôpital neurologique
🇫🇷Lyon, France