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NCT Number: NCT02033902

A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years

The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitatsklinikum Innsbruck, Innsbruck, Austria

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About this study

This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent
  • Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit
  • Patients who provide informed consent

Exclusion criteria

  • Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
  • Prior participation in a perampanel clinical study
  • Hypersensitivity to perampanel

Treatment and study plan

perampanel

Drug

Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment

Primary outcomes

  1. Number of Treatment Emergent Adverse Events (TEAEs) of interest

    Time frame: Up to 52 weeks and 2 weeks of follow-up

    Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.

Secondary outcomes

  1. Incidence of unintended pregnancy

    Time frame: Up to 52 weeks

  2. Incidence of off-label use

    Time frame: Up to 52 weeks

  3. Summary scores for the Hospital Anxiety and Depression Scale (HADS)

    Time frame: Screening, Week 52

  4. Number of TEAEs in the patient subpopulations of interest

    Time frame: Up to 52 weeks and 2 weeks of follow-up

    TEAEs observed in the specified subpopulations of patients could also be made in order to get a better understanding of whether any of these particular potential risk factors (e.g., old age, cardiovascular disease) define groups with greater or lesser risk.

  5. Clinical Global Impression of Change

    Time frame: Week 52

    Assessment of disease severity will utilize the Clinical Global Impression of Change (CGI-C) scale at end of treatment to evaluate change in disease status since initiation of treatment.

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2014
Registry last updated
Sep 7, 2018

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.

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