Skip to main content
OpenTrials
Completed

NCT Number: NCT02876289

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Refractory Epilepsy Brain Diseases Central Nervous System Diseases Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

16 year–86 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital neurologique

Lyon, 69002, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perampanel

Drug

Primary outcomes

  1. Retention rate

    Time frame: 6 months

    Proportion of patient still treated with Perampanel 6 months after its initiation

Secondary outcomes

  1. Retention rate

    Time frame: 12 months

    Proportion of patients still treated with Perampanel 12 months after its initiation

  2. Seizure freedom

    Time frame: 6 months

    Proportion of seizure-free patients during at least 6 months

  3. 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.

  4. 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.

  5. Total withdrawal rate

    Time frame: 6 months

    Discontinuation rates at 6 months due to inefficiency or adverse effects

  6. Total withdrawal rate

    Time frame: 12 months

    Discontinuation rates at 12 months due to inefficiency or adverse effects

  7. Observed adverse effects during the observation period

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PERLYON

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2016
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.