A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

This study has been terminated.
(Lack of enrollement)
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Jerzy P Szaflarski, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01110187
First received: April 16, 2010
Last updated: March 26, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Drug: lacosamide
Drug: Fosphenytoin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Number of Adverse Events [ Time Frame: baseline to 7 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Seizures [ Time Frame: baseline to 72 hours ] [ Designated as safety issue: No ]
    Number of seizures in the first 72 hours based on EEG recording


Enrollment: 11
Study Start Date: May 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV LCM (lacosamide)
Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.
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.
Other Name: Vimpat
Active Comparator: IV fPHT (fos-phenytoin)
Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin
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
Other Name: Dilantin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110187

Locations
United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219
UC Health Medical Arts Building
Cincinnati, Ohio, United States, 45219
UC Health University Pointe
Cincinnati, Ohio, United States, 45069
Sponsors and Collaborators
University of Alabama at Birmingham
UCB Pharma
Investigators
Principal Investigator: Jerzy P Szaflarski, M.D., PhD Univeristy of Cincinnati
  More Information

Publications:
Responsible Party: Jerzy P Szaflarski, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01110187     History of Changes
Other Study ID Numbers: JPS-001
Study First Received: April 16, 2010
Results First Received: June 19, 2013
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Lacosamide
Fosphenytoin
traumatic brain injury
Glasgow coma scale
Disability Rating Scale
Resource Utilization Questionnaire
Continuous EEG
seizures

Additional relevant MeSH terms:
Brain Injuries
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Epilepsy
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Fosphenytoin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014