Fycompa
DrugOral suspension
Other names: Perampanel
NCT Number: NCT03208660
This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.
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Observational
Arizona Age Reversal & Neurology Clinic, Phoenix, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral suspension
Other names: Perampanel
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
Time frame: Baseline, Up to 24 months
Change from baseline is calculated as the post-baseline value minus the baseline value.
Time frame: Baseline, Up to 24 months
Change from baseline is calculated as the post-baseline value minus the baseline value.
Time frame: Up to 24 months
The extent of exposure of Fycompa will be determined by summarizing the maximum dose of the study drug.
Time frame: Up to 24 months
The extent of exposure of Fycompa will be determined by summarizing the average dose of the study drug.
Eisai Inc.
Industry
A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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