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Trial Outcomes & Findings for A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide (NCT NCT01110187)

NCT ID: NCT01110187

Last Updated: 2014-04-28

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

baseline to 7 days

Results posted on

2014-04-28

Participant Flow

Participant milestones

Participant milestones
Measure
IV LCM
Patients with severe TBI later randomized to seizure prophylaxis with LCM (Lacosamide). For IV LCM dosing and adjustment see "Intervention" section.
IV fPHT
Patients randomized to fPHT (fos-phenytoin) with moderate or severe TBI. For IV fPHT dosing and adjustment see "Intervention" section.
Overall Study
STARTED
7
4
Overall Study
COMPLETED
7
4
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
IV LCM
n=7 Participants
patients randomized to IV LCM (7)
IV fPHT
n=4 Participants
patients randomized to IV fPHT (4)
Total
n=11 Participants
Total of all reporting groups
Age, Continuous
57 years
n=93 Participants
55.5 years
n=4 Participants
56 years
n=27 Participants
Sex: Female, Male
Female
3 Participants
n=93 Participants
0 Participants
n=4 Participants
3 Participants
n=27 Participants
Sex: Female, Male
Male
4 Participants
n=93 Participants
4 Participants
n=4 Participants
8 Participants
n=27 Participants

PRIMARY outcome

Timeframe: baseline to 7 days

Population: all participants in each arm were available for analyses

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.

Outcome measures

Outcome measures
Measure
IV LCM
n=7 Participants
Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
IV fPHT
n=4 Participants
Patients with severe TBI randomized to seizure prophylaxis with fPHT
Number of Adverse Events
12 number of events experienced
21 number of events experienced

SECONDARY outcome

Timeframe: baseline to 72 hours

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

Outcome measures

Outcome measures
Measure
IV LCM
n=7 Participants
Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
IV fPHT
n=4 Participants
Patients with severe TBI randomized to seizure prophylaxis with fPHT
Number of Participants With Seizures
0 number of participants with seizures
0 number of participants with seizures

Adverse Events

IV LCM

Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths

IV fPHT

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
IV LCM
n=7 participants at risk
Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
IV fPHT
n=4 participants at risk
Patients with severe TBI later randomized to seizure prophylaxis with phenytoin.
Nervous system disorders
death
28.6%
2/7 • Number of events 2 • baseline to 7 days
0.00%
0/4 • baseline to 7 days

Other adverse events

Other adverse events
Measure
IV LCM
n=7 participants at risk
Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
IV fPHT
n=4 participants at risk
Patients with severe TBI later randomized to seizure prophylaxis with phenytoin.
Investigations
fever
42.9%
3/7 • Number of events 3 • baseline to 7 days
75.0%
3/4 • Number of events 3 • baseline to 7 days
Nervous system disorders
increased ICP
0.00%
0/7 • baseline to 7 days
75.0%
3/4 • Number of events 3 • baseline to 7 days
Investigations
Hypotension
0.00%
0/7 • baseline to 7 days
25.0%
1/4 • Number of events 1 • baseline to 7 days
Hepatobiliary disorders
LFT
14.3%
1/7 • Number of events 1 • baseline to 7 days
75.0%
3/4 • Number of events 3 • baseline to 7 days
Nervous system disorders
stroke
14.3%
1/7 • Number of events 1 • baseline to 7 days
75.0%
3/4 • Number of events 3 • baseline to 7 days
Cardiac disorders
arrythmia
14.3%
1/7 • Number of events 1 • baseline to 7 days
75.0%
3/4 • Number of events 3 • baseline to 7 days
Blood and lymphatic system disorders
anemia
28.6%
2/7 • Number of events 2 • baseline to 7 days
50.0%
2/4 • Number of events 2 • baseline to 7 days
Blood and lymphatic system disorders
low platelets
28.6%
2/7 • Number of events 2 • baseline to 7 days
50.0%
2/4 • Number of events 2 • baseline to 7 days
Skin and subcutaneous tissue disorders
skin reaction
0.00%
0/7 • baseline to 7 days
25.0%
1/4 • Number of events 1 • baseline to 7 days

Additional Information

Jerzy P. Szaflarski, MD

University of Alabama at Birmingham

Phone: 205-934-3866

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place