A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

The University of Alabama at Birmingham

Status: Terminated

Conditions: Traumatic Brain Injury

Treatments: Drug: lacosamide; Drug: Fosphenytoin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01110187

JPS-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

IV LCM (lacosamide)

Experimental group

Description:

Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.

Treatment:

Drug: lacosamide

IV fPHT (fos-phenytoin)

Active Comparator group

Description:

Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin

Treatment:

Drug: Fosphenytoin