An observational study in Epilepsy, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Observational
The purpose of this study is to describe the effectiveness of the adjunctive ASM treatment on the clinical response, safety profile and quality of life of patients affected by focal onset seizures in a real-world setting.
The aim of the study is to assess the effectiveness and safety of adjunctive therapy in a real-world setting of patients affected by focal-onset seizures who are eligible to start the treatment with ASM as adjunctive therapy according to the physician's judgment.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 300 is above the median of 112 across 540 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with epilepsy having focal-onset seizures with or without secondary generalization not adequately controlled despite a history of treatment with at least 2 anti-seizure medications and who will meet all the inclusion and none of the exclusion study criteria.
The patients should be eligible to start a treatment with ASM as adjunctive therapy according to the physician's judgement, that must be clearly separated from the physician's decision to include the patient in the current study. The patients will be prospectively observed up to 12 months after having completed the related titration.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients having focal-onset seizures not adequately controlled despite a history of treatment with at least 2 ASM. The patients should be eligible to start a treatment with ASM as adjunctive therapy.The patients will be prospectively observed up to 12 months after having completed the related titration.
Other: ASM as adjunctive therapy
ASM approved as adjunctive therapy
Change in seizure frequency at 6 months of maintenance
The effectiveness of adjunctive ASM is measured as change in seizure frequency at 6 months of maintenance compared to baseline
Time frame: At 6 months of maintenance compared to baseline
Change in seizure frequency at 3, 9, 12 months of maintenance
The effectiveness of adjunctive ASM is measured as change in seizure frequency at 3, 9, 12 months of maintenance compared to baseline
Time frame: At 3, 9, 12 months of maintenance compared to baseline
50, 75, 90 Percent Responder rate
The effectiveness is measured as 50, 75, 90 Percent Responder rate
Time frame: At 3, 6, 9, and 12 months of maintenance phase.
100 Percent Responder rate
The effectiveness is measured as number/percentage of seizure free patients
Time frame: At 3, 6, 9, and 12 months of maintenance phase.
Retention rate
The effectiveness is measured as percentage of patients remaining in the study and on adjunctive therapy
Time frame: At 3, 6, 9, and 12 months of maintenance phase.
Anxiety assessment
The assessment is measured by means of the Generalized Anxiety Disorder (GAD-7) scale. Scoring GAD-7 Anxiety Severity is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety.
Time frame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
Depression assessment
The assessment is measured through the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) scale. This is a validated screening tool for depression in patients with epilepsy that consists of a 6- item questionnaire. NDDI-E scores greater than 15 were considered positive for depression, as this score was previously shown to have a specificity of 90%, sensitivity of 81%, and positive predictive value of 0.62 for a diagnosis of major depression.
Time frame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
Quality of life (QOL)
The quality of life is measured by means the Quality Of Life In Epilepsy (QOLIE-31-P) questionnaire. This is a 38 questions survey of health-related quality of life for adults (18 years or older) with epilepsy. This version differs from the original QOLIE-31 (version 1) in the addition of questions about how much distress you feel about problems and worries related to epilepsy. This questionnaire should be completed only by the person who has epilepsy (not a relative or friend). Patients are asked to answer every question by circling the appropriate number (1, 2, 3...).
Time frame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
Cognitive assessment
The assessment of perceived cognitive deficits is measured through the Perceived Deficits Questionnaire (PDQ-5). The PDQ-5 assesses cognitive dysfunction in people with depression. This patient-reported questionnaire includes five items measuring attention/concentration, retrospective memory, prospective memory, and planning/organization over the past four weeks. The total score ranges from 0 to 20; higher scores indicate greater perceived cognitive dysfunction.
Time frame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
Adverse events (AEs)
Number of Adverse events (AEs) occurred (including AEs of special interest as Drug Reaction with Eosinophilia and Systemic Symptoms, rash/hypersensitivity, etc.).
Time frame: Through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aziende Chimiche Riunite Angelini Francesco S.p.A →