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

• ClinicalTrials.gov Identifier: NCT03208660
• Recruitment Status: Completed
• First Posted: July 5, 2017
• Last Update Posted: April 11, 2019
• Sponsor: Eisai Inc.
• 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

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

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