NCT02736162

Brief Summary

The primary objective of this study is to assess the retention rate of perampanel when given as secondary monotherapy in routine clinical care.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

March 30, 2016

Last Update Submit

March 7, 2017

Conditions

EpilepsyPartial-Onset SeizuresPrimary Generalized Tonic-Clonic Seizures

Keywords

PerampanelE2007Phase 4Fycompa

Outcome Measures

Primary Outcomes (6)

  • Retention rate

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

    Month 3

  • Retention rate

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

    Month 6

  • Retention rate

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

    Month 12

  • Retention rate

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

    Month 18

  • Retention rate

    The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

    Month 24

  • Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)

    Up to approximately 34 months

Secondary Outcomes (11)

  • Percentage of participants receiving perampanel monotherapy out of the total number of participants prescribed perampanel

    Up to approximately 34 months

  • Percentage of participants with greater than or equal to 50% reduction in seizure frequency

    Up to approximately 34 months

  • Percentage of participants who were seizure-free for at least 3 months

    Up to approximately 34 months

  • Percentage of participants with greater than or equal to 75% reduction in seizure frequency

    Up to approximately 34 months

  • Percentage of participants with categorized percent reductions in seizure frequency

    Up to approximately 34 months

  • +6 more secondary outcomes

Study Arms (1)

Perampanel

Participants with a diagnosis of epilepsy who received perampanel as primary or secondary (conversion) monotherapy at any time between 1 Jan 2013 and 15 Oct 2015.

Other: No treatment (intervention) was administered

Interventions

No treatment (intervention) was administeredOTHER
Perampanel

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who received perampanel as primary or secondary monotherapy.

You may qualify if:

  • Diagnosis of epilepsy
  • Received perampanel as primary or secondary monotherapy at any time between 1 Jan 2013 and 15 Oct 2015
  • Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records per local requirements

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Karen Cartwright, PhD

    Eisai Limited

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 13, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

March 9, 2017

Record last verified: 2017-03