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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01110187
• Other study ID #: JPS-001
• Status: Terminated
• Phase: N/A
• First received: April 16, 2010
• Last updated: March 26, 2014
• Start date: May 2010
• Est. completion date: May 2012

Study information

• Verified date: February 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Drug:
• lacosamide
200 mg IV over 60 minutes; these patients will then be started on a maintenance dose 100 mg, IV BID as prophylaxis administered as per pharmacy protocol consistent with acceptable standards of care for 7 days. The Lacosamide dose can be adjusted as needed if seizures occur for therapeutic effect up to 200 mg bid (400 mg/d) as a maximum dose.
• Fosphenytoin
20 mgPE/kg IV over 60 minutes and then will be started on a maintenance dose (5 mgPE/kg/day, rounded to nearest dose of 150 mgPE IV, BID administered as per pharmacy protocol consistent with acceptable standards of care for 7 days

Locations

Country	Name	City	State
United States	UC Health Medical Arts Building	Cincinnati	Ohio
United States	UC Health University Pointe	Cincinnati	Ohio
United States	University Hospital	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	UCB Pharma

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	The primary outcome measure is the incidence of clinical adverse events. These will be followed by daily clinical observations during the hospital stay. Subjects will be evaluated for e.g., seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death; EKGs will be requested as per ICU routines through day 7.	baseline to 7 days	Yes
Secondary	Number of Participants With Seizures	Number of seizures in the first 72 hours based on EEG recording	baseline to 72 hours	No