EpilepsyNCT05867160
Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study
An observational study of Epilepsy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- ASM as adjunctive therapy
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2023to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Male and female patients of any ethnic origin ≥18 years old at baseline.
- Patients with diagnosis of focal-onset seizures with or without secondary generalization.
- Patients should have been eligible to start treatment with ASM as adjunctive therapy according to the physician's judgement prior to the inclusion.
- Patients should have clinical history of treatment failure with at least 2 ASMs.
- Patients using their seizure diary as part of their standard of care for at least 3 months prior to -the study entry (diary can be paper or electronic, filled in by patient and/or family members).
- Written informed consent (including data privacy consent) signed by the patient, legal guardian, or legally authorized representative prior to entering the study in accordance with the ICH GCP guidelines
Who cannot join
- Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC.
- Progressive neurological disease, including degenerative CNS diseases and progressive tumors.
- Patients with unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified assessments (e.g., in the judgement of the Investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months prior to enrollment, current psychotic disorder, acute mania).
- Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator could affect the participant's safety or interfere with study assessments.
- Patients with substance abuse or dependence (except for caffeine and nicotine).
- Patients participating in any pharmacological or nonpharmacological interventional study within 30 days prior to baseline.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto Neurologico "Carlo Besta" U.O. Epilettologia Clinica e Sperimentale - Centro di Medicina del Sonno
Milan, 20133
About this study
Official title: A 12-month, Prospective, Observational Study in Adult Patients With Focal Onset Seizures Who Are Treated With Adjunctive ASM in Real World Setting
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.
Read the detailed description
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.
- Conditions
- Epilepsy
- Being tested
- ASM as adjunctive therapy
- Keywords
- Epilepsy, Focal-onset seizure, Cenobamate, Adjunctive Therapy
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASM as adjunctive therapyOther
ASM approved as adjunctive therapy
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with focal-onset seizures starting a treatment with ASM as adjunctive therapy | 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. Receives: Other: ASM as adjunctive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 months of maintenance compared to baseline
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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...).
Measured: 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.
Measured: 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.).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start2 May 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867160
- Sponsor's protocol ID
- 169(A)MD21254
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month, Prospective, Observational Study in Adult Patients With Focal Onset Seizures Who Are Treated With Adjunctive ASM in Real World Setting
- ClinicalTrials.gov ID
- NCT05867160
- Acronym / sponsor ID
- 169(A)MD21254
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Focal-onset seizure, Cenobamate, Adjunctive Therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Hippocrates Research
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with focal-onset seizures starting a treatment with ASM as adjunctive therapy | – | Other: ASM as adjunctive therapyAdult 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Male and female patients of any ethnic origin ≥18 years old at baseline.
- Patients with diagnosis of focal-onset seizures with or without secondary generalization.
- Patients should have been eligible to start treatment with ASM as adjunctive therapy according to the physician's judgement prior to the inclusion.
- Patients should have clinical history of treatment failure with at least 2 ASMs.
- Patients using their seizure diary as part of their standard of care for at least 3 months prior to -the study entry (diary can be paper or electronic, filled in by patient and/or family members).
Key exclusion criteria (6 listed)
- Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC.
- Progressive neurological disease, including degenerative CNS diseases and progressive tumors.
- Patients with unstable psychiatric diagnosis that may confound participants' ability to participate in the study or that may prevent completion of the protocol-specified assessments (e.g., in the judgement of the Investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months prior to enrollment, current psychotic disorder, acute mania).
- Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator could affect the participant's safety or interfere with study assessments.
- Patients with substance abuse or dependence (except for caffeine and nicotine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASM as adjunctive therapyASM approved as adjunctive therapy | Other | Adult patients with focal-onset seizures starting a treatment with ASM as adjunctive therapy |
Primary outcome
Change in seizure frequency at 6 months of maintenance
Time frame: At 6 months of maintenance compared to baseline
The effectiveness of adjunctive ASM is measured as change in seizure frequency at 6 months of maintenance compared to baseline
9 secondary outcomes
Change in seizure frequency at 3, 9, 12 months of maintenance
Time frame: At 3, 9, 12 months of maintenance compared to baseline
50, 75, 90 Percent Responder rate
Time frame: At 3, 6, 9, and 12 months of maintenance phase.
100 Percent Responder rate
Time frame: At 3, 6, 9, and 12 months of maintenance phase.
Retention rate
Time frame: At 3, 6, 9, and 12 months of maintenance phase.
Anxiety assessment
Time frame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
Depression assessment
Time frame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
Quality of life (QOL)
Time frame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
Cognitive assessment
Time frame: At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.
Adverse events (AEs)
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in seizure frequency at 6 months of maintenance (time frame: At 6 months of maintenance compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.