Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
- Registration Number
- NCT03208660
- Lead Sponsor
- Eisai Inc.
- Brief Summary
This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
-
Participants must have met all of the following criteria to be included in this study:
- Diagnosis of epilepsy
- Initiated treatment with Fycompa at any time after 01 Jan 2014
- 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).
- Not applicable
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Fycompa Fycompa Participants diagnosed with epilepsy and treated with Fycompa
- Primary Outcome Measures
Name Time Method Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate) 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.
- Secondary Outcome Measures
Name Time Method Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa 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 height of pediatric participants from baseline Baseline, Up to 24 months Change from baseline is calculated as the post-baseline value minus the baseline value.
Maximum dose of Fycompa 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 Up to 24 months The extent of exposure of Fycompa will be determined by summarizing the average dose of the study drug.
Number of participants with a 50% response rate 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 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 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 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 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 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).
Mean change in body weight from baseline Baseline, Up to 24 months Change from baseline is calculated as the post-baseline value minus the baseline value.
Total provider health care visits before, during, and after final dose of Fycompa 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 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.
Trial Locations
- Locations (44)
Meridian Clinical Research
🇺🇸Savannah, Georgia, United States
Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Northeast Regional Epilepsy Group
🇺🇸Hackensack, New Jersey, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Seattle Children's Hospital - PIN
🇺🇸Seattle, Washington, United States
Nicklaus Children's Hospital
🇺🇸Miami, Florida, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Valley Children's Hospital
🇺🇸Madera, California, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Mid-Atlantic Epilepsy and Sleep Center
🇺🇸Bethesda, Maryland, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Pennsylvania
🇺🇸Pittsburgh, Pennsylvania, United States
MultiCare Institute for Research and Innovation
🇺🇸Tacoma, Washington, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
Northwest Neurology & Electrodiagnostic Center
🇺🇸Auburn, Washington, United States
Arizona Age Reversal & Neurology Clinic
🇺🇸Phoenix, Arizona, United States
Bronislava Shafran, MD, PC
🇺🇸Phoenix, Arizona, United States
Banner - University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Spectrum Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Icahn School of Medicine at Mount Sinai
🇺🇸Hartsdale, New York, United States
Northwell Health
🇺🇸New York, New York, United States
Arizona Neurological Institute
🇺🇸Sun City, Arizona, United States
Boca Raton Regional Hospital
🇺🇸Boca Raton, Florida, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States
The University of Arizona Department of Neurology
🇺🇸Tucson, Arizona, United States
Sutter Health
🇺🇸Sacramento, California, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Spectrum Health Medical Group
🇺🇸Grand Rapids, Michigan, United States
Albert Einstein College of Medicine
🇺🇸New York, New York, United States
Le Bonheur Children's Hospital - PIN
🇺🇸Memphis, Tennessee, United States
Auburn Neurological Institute
🇺🇸Auburn, Washington, United States
Consultants in Epilepsy & Neurology PLLC
🇺🇸Boise, Idaho, United States
Doctors hospital of Sarasota
🇺🇸Sarasota, Florida, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Capernaum Medical Center
🇺🇸Lakeland, Florida, United States
Intercoastal Medical Group
🇺🇸Sarasota, Florida, United States
Minnesota Epilepsy Group
🇺🇸Saint Paul, Minnesota, United States
Austin Epilepsy Center
🇺🇸Austin, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Pediatric Neurology PA
🇺🇸Orlando, Florida, United States