A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

NCT ID: NCT01110187

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-05-31

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

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

IV LCM (lacosamide)

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

Group Type: EXPERIMENTAL

lacosamide

Intervention Type: DRUG

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.

IV fPHT (fos-phenytoin)

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

Group Type: ACTIVE_COMPARATOR

Fosphenytoin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Vimpat; Dilantin

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jerzy P Szaflarski

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerzy P Szaflarski, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Cincinnati

Locations

UC Health University Pointe

Cincinnati, Ohio, United States

UC Health Medical Arts Building

Cincinnati, Ohio, United States

University Hospital

Cincinnati, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19898966 (View on PubMed)

Other Identifiers

JPS-001

Identifier Type: -

Identifier Source: org_study_id