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

NCT02876289 | Completed

• 1 other identifier: 69HCL16_0556
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

Refractory Epilepsy

Outcome Measures

Primary Outcomes (1)

• Retention rate

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

  6 months

Secondary Outcomes (7)

• Retention rate

  12 months

• Seizure freedom

  6 months

• Responder rates

  6 months

• Responder rates

  12 months

• Total withdrawal rate

  6 months

Study Arms (1)

patients treated with Perampanel

Drug: Perampanel

Interventions

Perampanel DRUG

patients treated with Perampanel

Eligibility Criteria

• Age: 16 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with refractory focal epilepsy
• Initiation of perampanel between 05/2014 and 04/2015

You may not qualify if:

• Exact date of initiation of Perampanel not defined
• Patients without follow-up data

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital neurologique

Lyon, 69002, France

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sylvain RHEIMS

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 24, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)