ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01110187
Recruitment Status : Terminated (Lack of enrollement)
First Posted : April 26, 2010
Results First Posted : April 28, 2014
Last Update Posted : April 28, 2014
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Jerzy P Szaflarski, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: lacosamide Drug: Fosphenytoin Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
Study Start Date : May 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: baseline to 7 days ]
    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 :
  1. Number of Participants With Seizures [ Time Frame: baseline to 72 hours ]
    Number of seizures in the first 72 hours based on EEG recording



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110187


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

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
First Posted: April 26, 2010    Key Record Dates
Results First Posted: April 28, 2014
Last Update Posted: April 28, 2014
Last Verified: February 2014

Keywords provided by Jerzy P Szaflarski, 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
Brain Injuries, Traumatic
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