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Study of Lacosamide in patients suffering from Epilepsy OR seizures

A Real world Observational, longitudinal, prospective, case-cohort, multicenter study to evaluate the safety, effectiveness, clinical utility of Lacosamide & its impact on cognitive impairment in patients suffering from Epilepsy in Indian context - ROLE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/098047
Enrollment
250
Registered
2025-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Yakshdeep Dave PhD Research Scholar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or female patients more than 18 to less than 75 years suffering from all types of epilepsy and treated with oral Lacosamide either as monotherapy or as an adjuvant therapy. Patients followed up for 12 months. Patients should have 2 reported follow up (between 1 to 12 months) following dose titration.

Exclusion criteria

Exclusion criteria: Patient aged less than 18 years and more than 75 years to be excluded. Cases with incomplete medical records Patients with hypersensitivity to lacosamide Uncontrolled metabolic disorders like, hypertension, T2DM, dyslipidemia, thyroids disorders etc. Patients with compromised liver/renal/cardiac functions Epilepsy patients treated with IV lacosamide Hospitalized Epilepsy patients

Design outcomes

Primary

MeasureTime frame
Change in MoCA cognitive scale from baseline to 6 months and 12 months % reduction in seizure frequency/month from baseline to at 6 months and 12 months Patients achieving continuous seizure freedom at 6 months and 12 monthsTimepoint: At baseline, 6 months & 12 months

Secondary

MeasureTime frame
Occurrence of AE/SAE/discontinuation from LCM therapy Sociodemographic analysis of patients Evaluation of drug utilization pattern in epilepsy Patients achieving seizure freedom at 6 months & 12 monthsTimepoint: At baseline, 6 months & 12 months

Countries

India

Contacts

Public ContactYakshdeep Dave

NIRMA UNIVERSITY

shital.panchal@nirmauni.ac.in9687626589

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026