Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)

Refractory Epilepsy Clinical Trial

— PERLYON  

Official title:

Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876289
• Other study ID #: 69HCL16_0556
• Status: Completed
• Phase: N/A
• First received: August 18, 2016
• Last updated: August 23, 2016
• Start date: May 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 86 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Drug:
• Perampanel

Locations

Country	Name	City	State
France	Hôpital neurologique	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate	Proportion of patient still treated with Perampanel 6 months after its initiation	6 months	No
Secondary	Retention rate	Proportion of patients still treated with Perampanel 12 months after its initiation	12 months	No
Secondary	Seizure freedom	Proportion of seizure-free patients during at least 6 months	6 months	No
Secondary	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.	6 months	No
Secondary	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.	12 months	No
Secondary	Total withdrawal rate	Discontinuation rates at 6 months due to inefficiency or adverse effects	6 months	Yes
Secondary	Total withdrawal rate	Discontinuation rates at 12 months due to inefficiency or adverse effects	12 months	Yes
Secondary	Observed adverse effects during the observation period		12 months	Yes