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Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures (FYC02T)

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ClinicalTrials.gov Identifier: NCT03059381
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Tracking Information
First Submitted Date February 17, 2017
First Posted Date February 23, 2017
Last Update Posted Date July 2, 2019
Actual Study Start Date August 1, 2016
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 20, 2017)
  • Number of participants with any serious adverse event [ Time Frame: from 0 to 104 weeks ]
  • Number of participants with any non-serious adverse event [ Time Frame: from 0 to 104 weeks ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03059381 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 20, 2017)
  • Number of participants experiencing seizures [ Time Frame: from 0 to 104 weeks ]
  • Overall improvement rating in seizure frequency [ Time Frame: from 0 to 104 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Official Title Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Brief Summary

The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:

  1. unknown adverse drug reactions (ADRs);
  2. occurrence of ADRs;
  3. factors that are likely to affect safety and efficacy;
  4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
  5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with epilepsy who will receive Fycompa per the approved indication in routine clinical practice
Condition
  • Partial Seizures (With or Without Secondary Generalized Seizures)
  • Primary Generalized Tonic-clonic Seizures
Intervention Drug: Fycompa
The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.
Study Groups/Cohorts Fycompa-treated epilepsy participants
Adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa
Intervention: Drug: Fycompa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 1, 2019)
519
Original Estimated Enrollment
 (submitted: February 20, 2017)
500
Estimated Study Completion Date February 28, 2022
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Epilepsy participants from 12 to 17 years of age with:

    • Partial seizures (with or without secondary generalized seizures)
    • Primary generalized Tonic-clonic seizures

Exclusion Criteria:

  • Participants previously treated with Fycompa
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03059381
Other Study ID Numbers E2007-M081-503
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Eisai Inc. ( Eisai Co., Ltd. )
Study Sponsor Eisai Co., Ltd.
Collaborators Not Provided
Investigators
Study Director: Kenta Sumitomo Drug Fostering and Evolution Coordination Department. Medical Division
PRS Account Eisai Inc.
Verification Date August 2018