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

August 23, 2016 updated by: Hospices Civils de Lyon

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69002
        • Hôpital neurologique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 86 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with refractory focal epilepsy in which Perampanel were introduced between May 2014 and April 2015

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients treated with Perampanel
Drug: Perampanel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rate
Time Frame: 6 months
Proportion of patient still treated with Perampanel 6 months after its initiation
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rate
Time Frame: 12 months
Proportion of patients still treated with Perampanel 12 months after its initiation
12 months
Seizure freedom
Time Frame: 6 months
Proportion of seizure-free patients during at least 6 months
6 months
Responder rates
Time Frame: 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.
6 months
Responder rates
Time Frame: 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.
12 months
Total withdrawal rate
Time Frame: 6 months
Discontinuation rates at 6 months due to inefficiency or adverse effects
6 months
Total withdrawal rate
Time Frame: 12 months
Discontinuation rates at 12 months due to inefficiency or adverse effects
12 months
Observed adverse effects during the observation period
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sylvain RHEIMS, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (ESTIMATE)

August 23, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 24, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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