A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Traumatic Brain Injury Clinical Trial

Official title: A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Status Terminated

Clinical Trial Summary

Trial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing clinical and sub-clinical seizure activity.

Clinical Trial Description

The goals are to compare IV LCM and IV fPHT for seizure prophylaxis in the neuro-critical care setting in terms of the following outcome measures:

1. The short- and long-term incidence of adverse events related to the anticonvulsant medication

2. The frequency of clinically-evident and sub-clinical seizures, as demonstrated by continuous EEG monitoring for the first three days and by clinical assessment for up to 6 months after initial admission.

3. Intermediate and long-term outcomes as measured by standard outcome measures including Extended Glasgow Outcome Scale, Disability Rating Scale, and Resource Utilization Questionnaire ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

• NCT number: NCT01110187
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Terminated
• Phase: N/A
• Start date: May 2010
• Completion date: May 2012