Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study

NCT05867160 | Active Not Recruiting

• 1 other identifier: 169(A)MD21254
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Keywords

Epilepsy; Focal-onset seizure; Cenobamate; Adjunctive Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  At 6 months of maintenance compared to baseline

Secondary Outcomes (9)

• Change in seizure frequency at 3, 9, 12 months of maintenance

  At 3, 9, 12 months of maintenance compared to baseline

• 50, 75, 90 Percent Responder rate

  At 3, 6, 9, and 12 months of maintenance phase.

• 100 Percent Responder rate

  At 3, 6, 9, and 12 months of maintenance phase.

• Retention rate

  At 3, 6, 9, and 12 months of maintenance phase.

• Anxiety assessment

  At baseline, immediately after completion of titration, at 3 months, 6 months, and 12 months of maintenance phase.

Study Arms (1)

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.

Other: ASM as adjunctive therapy

Interventions

ASM as adjunctive therapy OTHER

ASM approved as adjunctive therapy

Adult patients with focal-onset seizures starting a treatment with ASM as adjunctive therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Hippocrates Research: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Neurologico "Carlo Besta" U.O. Epilettologia Clinica e Sperimentale - Centro di Medicina del Sonno

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: May 19, 2023
• Study Start: May 2, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)