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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208660
• Other study ID #: E2007-G000-506
• Status: Completed
• Start date: April 7, 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Fycompa
Oral suspension

Locations

Country	Name	City	State
United States	Auburn Neurological Institute	Auburn	Washington
United States	Northwest Neurology & Electrodiagnostic Center	Auburn	Washington
United States	Austin Epilepsy Center	Austin	Texas
United States	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	Consultants in Epilepsy & Neurology PLLC	Boise	Idaho
United States	Tufts Medical Center	Boston	Massachusetts
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Spectrum Health System	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	Spectrum Health Medical Group	Grand Rapids	Michigan
United States	Northeast Regional Epilepsy Group	Hackensack	New Jersey
United States	Icahn School of Medicine at Mount Sinai	Hartsdale	New York
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Capernaum Medical Center	Lakeland	Florida
United States	Valley Children's Hospital	Madera	California
United States	Le Bonheur Children's Hospital - PIN	Memphis	Tennessee
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Albert Einstein College of Medicine	New York	New York
United States	Columbia University Medical Center	New York	New York
United States	Northwell Health	New York	New York
United States	Nemours Children's Hospital	Orlando	Florida
United States	Pediatric Neurology PA	Orlando	Florida
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Arizona Age Reversal & Neurology Clinic	Phoenix	Arizona
United States	Banner - University Medical Center Phoenix	Phoenix	Arizona
United States	Bronislava Shafran, MD, PC	Phoenix	Arizona
United States	Pennsylvania	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Sutter Health	Sacramento	California
United States	UC Davis Medical Center	Sacramento	California
United States	Minnesota Epilepsy Group	Saint Paul	Minnesota
United States	Doctors hospital of Sarasota	Sarasota	Florida
United States	Intercoastal Medical Group	Sarasota	Florida
United States	Meridian Clinical Research	Savannah	Georgia
United States	Seattle Children's Hospital - PIN	Seattle	Washington
United States	Arizona Neurological Institute	Sun City	Arizona
United States	MultiCare Institute for Research and Innovation	Tacoma	Washington
United States	University of South Florida	Tampa	Florida
United States	The University of Arizona Department of Neurology	Tucson	Arizona
United States	Carle Foundation Hospital	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate)	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.	3, 6, 12, 18, and 24 months
Secondary	Number of participants with a 50% response rate	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.	up to 24 months
Secondary	Number of participants with a 75% response rate	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.	up to 24 months
Secondary	Number of participants with a 100% response rate	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.	up to 24 months
Secondary	Categorized percent reduction in seizure frequency from baseline	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).	Baseline, up to 24 months
Secondary	Median percent change in seizure frequency from baseline	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).	Baseline, up to 24 months
Secondary	Percentage of participants who had no change or a worsening of seizures from baseline	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).	Baseline, up to 24 months
Secondary	Total provider health care visits before, during, and after final dose of Fycompa	Total provider health care visits before, during, and after final dose of Fycompa will be summarized as a safety variable.	6 months before initiation of Fycompa to 6 months after last dose of Fycompa
Secondary	Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of Fycompa	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.	Up to 24 months
Secondary	Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa	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.	Up to 24 months
Secondary	Mean change in body weight from baseline	Change from baseline is calculated as the post-baseline value minus the baseline value.	Baseline, Up to 24 months
Secondary	Mean change in height of pediatric participants from baseline	Change from baseline is calculated as the post-baseline value minus the baseline value.	Baseline, Up to 24 months
Secondary	Maximum dose of Fycompa	The extent of exposure of Fycompa will be determined by summarizing the maximum dose of the study drug.	Up to 24 months
Secondary	Average dose of Fycompa	The extent of exposure of Fycompa will be determined by summarizing the average dose of the study drug.	Up to 24 months