A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
| Status: | Archived |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2010 |
| End Date: | November 2012 |
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.
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
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials