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A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Traumatic Brain Injury
Interventions Drug: lacosamide
Drug: Fosphenytoin
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV LCM IV fPHT
Hide Arm/Group Description Patients with severe TBI later randomized to seizure prophylaxis with LCM (Lacosamide). For IV LCM dosing and adjustment see "Intervention" section. Patients randomized to fPHT (fos-phenytoin) with moderate or severe TBI. For IV fPHT dosing and adjustment see "Intervention" section.
Period Title: Overall Study
Started 7 4
Completed 7 [1] 4 [1]
Not Completed 0 0
[1]
completed 7 day treatment
Arm/Group Title IV LCM IV fPHT Total
Hide Arm/Group Description patients randomized to IV LCM (7) patients randomized to IV fPHT (4) Total of all reporting groups
Overall Number of Baseline Participants 7 4 11
Hide Baseline Analysis Population Description
Traumatic Brain Injury
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 4 participants 11 participants
57
(38 to 66)
55.5
(23 to 61)
56
(23 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 4 participants 11 participants
Female
3
  42.9%
0
   0.0%
3
  27.3%
Male
4
  57.1%
4
 100.0%
8
  72.7%
1.Primary Outcome
Title Number of Adverse Events
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
all participants in each arm were available for analyses
Arm/Group Title IV LCM IV fPHT
Hide Arm/Group Description:
Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
Patients with severe TBI randomized to seizure prophylaxis with fPHT
Overall Number of Participants Analyzed 7 4
Measure Type: Number
Unit of Measure: number of events experienced
12 21
2.Secondary Outcome
Title Number of Participants With Seizures
Hide Description Number of seizures in the first 72 hours based on EEG recording
Time Frame baseline to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV LCM IV fPHT
Hide Arm/Group Description:

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

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.

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

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

Overall Number of Participants Analyzed 7 4
Measure Type: Number
Unit of Measure: number of participants with seizures
0 0
Time Frame baseline to 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV LCM IV fPHT
Hide Arm/Group Description Patients with severe TBI later randomized to seizure prophylaxis with lacosamide. Patients with severe TBI later randomized to seizure prophylaxis with phenytoin.
All-Cause Mortality
IV LCM IV fPHT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IV LCM IV fPHT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      0/4 (0.00%)    
Nervous system disorders     
death  [1]  2/7 (28.57%)  2 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
death because of baseline condition (TBI) - expected
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV LCM IV fPHT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/7 (100.00%)      4/4 (100.00%)    
Blood and lymphatic system disorders     
anemia   2/7 (28.57%)  2 2/4 (50.00%)  2
low platelets   2/7 (28.57%)  2 2/4 (50.00%)  2
Cardiac disorders     
arrythmia   1/7 (14.29%)  1 3/4 (75.00%)  3
Hepatobiliary disorders     
LFT   1/7 (14.29%)  1 3/4 (75.00%)  3
Investigations     
fever   3/7 (42.86%)  3 3/4 (75.00%)  3
Hypotension   0/7 (0.00%)  0 1/4 (25.00%)  1
Nervous system disorders     
increased ICP   0/7 (0.00%)  0 3/4 (75.00%)  3
stroke   1/7 (14.29%)  1 3/4 (75.00%)  3
Skin and subcutaneous tissue disorders     
skin reaction   0/7 (0.00%)  0 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
Early termination due to lack of enrollment. Statistical comparisons between groups are not possible and were not performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jerzy P. Szaflarski, MD
Organization: University of Alabama at Birmingham
Phone: 205-934-3866
Responsible Party: Jerzy P Szaflarski, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01110187     History of Changes
Other Study ID Numbers: JPS-001
First Submitted: April 16, 2010
First Posted: April 26, 2010
Results First Submitted: June 19, 2013
Results First Posted: April 28, 2014
Last Update Posted: April 28, 2014