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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients affected by epilepsy with focal-onset seizures with or without secondary generalization | Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications (ASMs). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenobamate | Drug | Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate | To describe the ≥50% responder rate during the 6 and 12 months of maintenance-dosing treatment with cenobamate with respect to the pretreatment baseline. | At 6 and at 12 months of maintenance treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate | To describe the ≥75%/≥90%/=100% responder rate during the 6 and 12 months of maintenance-dosing treatment with cenobamate with respect to the pre-treatment baseline. | At 6 and at 12 months of maintenance-dosing treatment |
| Safety evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications (ASMs).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valeria Tellone | Contact | +393452493461 | valeria.tellone@angelinipharma.com | |
| Enrica Salvatori | Contact | +39 3458063168 | Enrica.salvatori@angelinipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital TARNIER COCHIN | Recruiting | Paris | France | France |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000654784 | Cenobamate |
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To describe real-world safety from treatment initiation until 12 months of maintenance-dosing treatment with cenobamate. Absolute and relative frequencies of patients treated with cenobamate who experienced at least one AE/Adverse Drug Reaction (ADR)/Serious Adverse Event (SAE)/Serious Adverse Drug Reaction (SADR)/AE of special interest during the observation period. Total number of AEs/ADRs/SAEs/SADRs/AEs of special interest occurred during the observation period. |
| 0 -12 months of maintenance-dosing treatment |
| Health-Related Quality of Life evaluation (QOLIE-31-P) | QOLIE-31-P is a survey of health-related quality of life for adults with epilepsy. This questionnaire should be completed only by the person who has epilepsy (not a relative or friend). There are 39 questions about health and daily activities.The QOLIE-31-P consists of 38 self-reported items and is divided in eight parts which evaluate energy, mood, daily activities, cognition, medication effects, seizure worry, overall QoL , and health state. The first and the last items are scored with 0-10 and 0-100 scales, respectively, from the worst to the best situation. The remaining 36 items are scored using a Likert rating scale from 1 to 3,4,5, or 6. The raw scores are reorganized to have scores from 0 to 100. The final score is obtained from the subscale scores and is rescaled from 0 to 100 with higher scores associated with better QoL. | At 6 and at 12 months maintenance-dosing treatment |
| Health-Related Quality of Life evaluation (SF-6Dv2 ) | The SF-6Dv2 Health Utility Survey provides keen insights into patient health and product performance by measuring six health domains. The SF-6Dv2™ Health Survey consists of six questions asking about different aspects of patient's health; for each question, patients should select the response (among 5 or 6 options per question) that best describe his/her health status. | At 6 and at 12 months maintenance-dosing treatment |
| Sleepiness status evaluation | To describe the sleepiness status of patients, by means of the Epworth Sleepiness Scale (ESS), at 6 and at 12 months of maintenance-dosing treatment with cenobamate. The ESS scale is designed to measure the patient's general level of daytime sleepiness. The ESS scale is designed to measure the patient's general level of daytime sleepiness and consists of 8 questions with a rating ranging from "0 = no chance of dozing" to "3 = high chance of dozing". | At 6 and at 12 months of maintenance-dosing treatment |
| Healthcare resource evaluation | Absolute and relative frequencies of patients according to the type of resources used (ED accesses; inpatient hospitalizations; specialist outpatient visits; diagnostic exams) during the observation period. Descriptive statistics (mean, SD, median, 25th and 75th percentiles, min. and max.) of total number of resources used (ED accesses; inpatient hospitalizations; specialist outpatient visits; diagnostic exams) during the observation period. Descriptive statistics (mean, SD, median, 25th and 75th percentiles, min. and max.) of total duration of inpatient hospitalizations (calculated for each patient by summing the duration of all his/her inpatient hospitalizations) during the observation period. | 0-12 months of maintenance-dosing treatment |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |