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A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Primary Purpose

Traumatic Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lacosamide
Fosphenytoin
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Traumatic Brain Injury focused on measuring Lacosamide, Fosphenytoin, traumatic brain injury, Glasgow coma scale, Disability Rating Scale, Resource Utilization Questionnaire, Continuous EEG, seizures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UC Health University Pointe
  • UC Health Medical Arts Building
  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IV LCM (lacosamide)

IV fPHT (fos-phenytoin)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Seizures
Number of seizures in the first 72 hours based on EEG recording

Full Information

First Posted
April 16, 2010
Last Updated
March 26, 2014
Sponsor
University of Alabama at Birmingham
Collaborators
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01110187
Brief Title
A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
Official Title
A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollement
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
UCB Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: The short- and long-term incidence of adverse events related to the anticonvulsant medication 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. Intermediate and long-term outcomes as measured by standard outcome measures including Extended Glasgow Outcome Scale, Disability Rating Scale, and Resource Utilization Questionnaire

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Lacosamide, Fosphenytoin, traumatic brain injury, Glasgow coma scale, Disability Rating Scale, Resource Utilization Questionnaire, Continuous EEG, seizures

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV LCM (lacosamide)
Arm Type
Experimental
Arm Description
Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.
Arm Title
IV fPHT (fos-phenytoin)
Arm Type
Active Comparator
Arm Description
Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin
Intervention Type
Drug
Intervention Name(s)
lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
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
Intervention Name(s)
Fosphenytoin
Other Intervention Name(s)
Dilantin
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Adverse Events
Description
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.
Time Frame
baseline to 7 days
Secondary Outcome Measure Information:
Title
Number of Participants With Seizures
Description
Number of seizures in the first 72 hours based on EEG recording
Time Frame
baseline to 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerzy P Szaflarski, M.D., PhD
Organizational Affiliation
Univeristy of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Health University Pointe
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
UC Health Medical Arts Building
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19898966
Citation
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.
Results Reference
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A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

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