Real-World epilepsy study tracks Add-On drug effectiveness
NCT ID NCT05867160
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study follows 300 adults with focal epilepsy who are starting an additional anti-seizure medication (ASM) alongside their current treatment. Researchers will track changes in seizure frequency and quality of life over 12 months in everyday clinical settings. The goal is to see how well these add-on drugs work outside of strict trial conditions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- anti-seizure medication (ASM) as add-on therapy
- What this could lead to
- If successful, this study could help doctors understand which add-on seizure medicines work best in everyday settings for people with hard-to-control focal seizures.
- What could go wrong
- This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients, and there is no new treatment being tested.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Sep 2025
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fondazione IRCCS Istituto Neurologico "Carlo Besta" U.O. Epilettologia Clinica e Sperimentale - Centro di Medicina del Sonno
Milan, 20133, Italy
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