Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)
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StatusCompleted
Sponsors
Hospices Civils de Lyon
CLINICAL TRIAL: NCT02876289
BioSeek: NCT02876289
Keywords
Abstract
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).
Dates
| Last Verified: | 07/31/2016 |
| First Submitted: | 08/17/2016 |
| Estimated Enrollment Submitted: | 08/17/2016 |
| First Posted: | 08/22/2016 |
| Last Update Submitted: | 08/22/2016 |
| Last Update Posted: | 08/23/2016 |
| Actual Study Start Date: | 04/30/2014 |
| Estimated Primary Completion Date: | 08/31/2015 |
| Estimated Study Completion Date: | 08/31/2015 |
Condition or disease
Refractory Epilepsy
Intervention/treatment
Drug: patients treated with Perampanel
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| patients treated with Perampanel | Drug: patients treated with Perampanel |
Eligibility Criteria
| Ages Eligible for Study | 16 Years To 16 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Patients with refractory focal epilepsy - Initiation of perampanel between 05/2014 and 04/2015 Exclusion Criteria: - Exact date of initiation of Perampanel not defined - Patients without follow-up data |
Outcome
Primary Outcome Measures
1. Retention rate [6 months]
Proportion of patient still treated with Perampanel 6 months after its initiation
Secondary Outcome Measures
1. Retention rate [12 months]
Proportion of patients still treated with Perampanel 12 months after its initiation
2. Seizure freedom [6 months]
Proportion of seizure-free patients during at least 6 months
3. Responder rates [6 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.
4. 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.
5. Total withdrawal rate [6 months]
Discontinuation rates at 6 months due to inefficiency or adverse effects
6. Total withdrawal rate [12 months]
Discontinuation rates at 12 months due to inefficiency or adverse effects
7. Observed adverse effects during the observation period [12 months]
