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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

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ClinicalTrials.gov Identifier: NCT02033902
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Epilepsy Drug: Perampanel

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : June 6, 2014
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Perampanel

Group/Cohort Intervention/treatment
Perampanel
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment
Drug: Perampanel
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Epilepsy patients prescribed adjunctive treatment in countries where perampanel has received marketing approval. Multiple treating physicians will prescribe perampanel to patients, who then will be observed for approximately 52 weeks.
Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033902


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Sponsors and Collaborators
Eisai Inc.

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT02033902     History of Changes
Other Study ID Numbers: E2007-G000-402
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: November 2015
Keywords provided by Eisai Inc.:
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases