A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: UCB Pharma
• Treatments: Fosphenytoin; Lacosamide

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