Clinical trial NCT01110187: A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
Official title: A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Lacosamide
Fosphenytoin
traumatic brain injury
Glasgow coma scale
Disability Rating Scale
Resource Utilization Questionnaire
Continuous EEG
seizures
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2010-04-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Subject with traumatic brain injury admitted to the hospital less than 24 hours prior to randomization
* GCS score 3-8 (inclusive) or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
* Hemodynamically stable with a systolic BP \> 90 mmHg
* At least one reactive pupil
* Age at least 18 years
* Signed informed consent and HIPAA authorization for research form
* Patients will not be excluded because of race, gender, educational status or occupation

Exclusion Criteria:

* No venous access
* Spinal cord injury
* History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
* Hemodynamically unstable
* Suspected anoxic events
* Other peripheral trauma likely to result in liver failure
* Age less than 18 years of age
* Known hypersensitivity to any anticonvulsant
* Any treatment, condition, or injury that contraindicates treatment with Lacosamide (LCM) or fos-phenytoin (fPHT)
* Inability to obtain signed informed consent or HIPAA authorization for research

Primary outcomes:
measure: Number of Adverse Events
timeFrame: baseline to 7 days
Secondary outcomes:
measure: Number of Participants With Seizures
timeFrame: baseline to 72 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: UC Health University Pointe
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Medical Arts Building
state: Ohio
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: Univeristy of Cincinnati
name: Jerzy P Szaflarski, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szaflarski JP, Sangha KS, Lindsell CJ, Shutter LA. Prospective, randomized, single-blinded comparative trial of intravenous levetiracetam versus phenytoin for seizure prophylaxis. Neurocrit Care. 2010 Apr;12(2):165-72. doi: 10.1007/s12028-009-9304-y.