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Trial record 83 of 146 for:    epilepsy AND Bethesda

Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy

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ClinicalTrials.gov Identifier: NCT03208660
Recruitment Status : Completed
First Posted : July 5, 2017
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Tracking Information
First Submitted Date July 3, 2017
First Posted Date July 5, 2017
Last Update Posted Date April 11, 2019
Actual Study Start Date April 7, 2017
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2017)
Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate) [ Time Frame: 3, 6, 12, 18, and 24 months ]
Retention rate is the ratio of the number of participants remaining on Fycompa treatment to the number of participants who could have been exposed for that length of time.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03208660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 3, 2017)
  • Number of participants with a 50% response rate [ Time Frame: up to 24 months ]
    The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.
  • Number of participants with a 75% response rate [ Time Frame: up to 24 months ]
    The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.
  • Number of participants with a 100% response rate [ Time Frame: up to 24 months ]
    The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.
  • Categorized percent reduction in seizure frequency from baseline [ Time Frame: Baseline, up to 24 months ]
    An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).
  • Median percent change in seizure frequency from baseline [ Time Frame: Baseline, up to 24 months ]
    An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).
  • Percentage of participants who had no change or a worsening of seizures from baseline [ Time Frame: Baseline, up to 24 months ]
    An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).
  • Total provider health care visits before, during, and after final dose of Fycompa [ Time Frame: 6 months before initiation of Fycompa to 6 months after last dose of Fycompa ]
    Total provider health care visits before, during, and after final dose of Fycompa will be summarized as a safety variable.
  • Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of Fycompa [ Time Frame: Up to 24 months ]
    An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse events [AE] as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
  • Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa [ Time Frame: Up to 24 months ]
    An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
  • Mean change in body weight from baseline [ Time Frame: Baseline, Up to 24 months ]
    Change from baseline is calculated as the post-baseline value minus the baseline value.
  • Mean change in height of pediatric participants from baseline [ Time Frame: Baseline, Up to 24 months ]
    Change from baseline is calculated as the post-baseline value minus the baseline value.
  • Maximum dose of Fycompa [ Time Frame: Up to 24 months ]
    The extent of exposure of Fycompa will be determined by summarizing the maximum dose of the study drug.
  • Average dose of Fycompa [ Time Frame: Up to 24 months ]
    The extent of exposure of Fycompa will be determined by summarizing the average dose of the study drug.
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 Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
Official Title A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
Brief Summary This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Data will be obtained by reviewing the medical records of the participants with a diagnosis of epilepsy and treated with Fycompa on clinician's recommendation at up to approximately 40 epilepsy centers.
Condition Epilepsy
Intervention Drug: Fycompa
Oral suspension
Other Name: Perampanel
Study Groups/Cohorts Fycompa
Participants diagnosed with epilepsy and treated 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 Completed
Actual Enrollment
 (submitted: July 3, 2017)
2000
Original Estimated Enrollment Same as current
Actual Study Completion Date March 15, 2019
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants must have met all of the following criteria to be included in this study:

    1. Diagnosis of epilepsy
    2. Initiated treatment with Fycompa at any time after 01 Jan 2014
    3. Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records (if required by an Institutional Review Board [IRB] or Independent Ethics Committee [IEC], or by regulatory authorities).

Exclusion Criteria:

  • Not applicable
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03208660
Other Study ID Numbers E2007-G000-506
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Eisai Inc.
Study Sponsor Eisai Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Eisai Inc.
Verification Date March 2019