A Multicenter, Open-Label, Follow-Up Study to Assess the Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502639-21-00

Acronym

EP0151

Enrollment

Registered

2023-03-27

Start date

2020-12-28

Completion date

2025-02-11

Last updated

2024-11-22

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

Conditions

Epilepsy

Brief summary

1. Incidence of treatment-emergent adverse events (TEAEs) 2. Withdrawals from study due to TEAEs 3. Withdrawals from study due to Serious Adverse Event (SAEs) 4. Modal daily dose during the study 5. Maximum daily dose during the study

Detailed description

Not applicable

Interventions

DRUGlacosamide PRD236256

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
1. Incidence of treatment-emergent adverse events (TEAEs) 2. Withdrawals from study due to TEAEs 3. Withdrawals from study due to Serious Adverse Event (SAEs) 4. Modal daily dose during the study 5. Maximum daily dose during the study	—

Secondary

Measure	Time frame
Not applicable	—

Countries

Hungary, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026