An interventional study of lacosamide and Fosphenytoin in Traumatic Brain Injury, sponsored by University of Alabama at Birmingham. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-28.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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.
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:
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's enrollment of 11 is below the median of 55 across 1,158 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →University of Alabama at Birmingham is the lead sponsor of 1,415 studies on the registry; 277 are open to participants now.
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Exclusion Criteria:
Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.
Drug: lacosamide
Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin
Drug: Fosphenytoin
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.
Also known as: Vimpat
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
Also known as: Dilantin
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.
Time frame: baseline to 7 days
Number of Participants With Seizures
Number of seizures in the first 72 hours based on EEG recording
Time frame: baseline to 72 hours
| Milestone | IV LCM | IV fPHT |
|---|---|---|
| Started | 7 | 4 |
| Completed | 7 | 4 |
| Not completed | 0 | 0 |
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.
| number of events experienced | IV LCM | IV fPHT |
|---|---|---|
| Number of Adverse Events | 12 | 21 |
Number of seizures in the first 72 hours based on EEG recording
| number of participants with seizures | IV LCM | IV fPHT |
|---|---|---|
| Number of Participants With Seizures | 0 | 0 |
Collected over baseline to 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV LCM | — | 2/7 (28.6%) | 7/7 (100%) |
| IV fPHT | — | 0/4 (0%) | 4/4 (100%) |
| Event | IV LCM | IV fPHT |
|---|---|---|
| deathNervous system disorders | 2/7 | 0/4 |
| Event | IV LCM | IV fPHT |
|---|---|---|
| feverInvestigations | 3/7 | 3/4 |
| increased ICPNervous system disorders | 0/7 | 3/4 |
| LFTHepatobiliary disorders | 1/7 | 3/4 |
| strokeNervous system disorders | 1/7 | 3/4 |
| arrythmiaCardiac disorders | 1/7 | 3/4 |
| anemiaBlood and lymphatic system disorders | 2/7 | 2/4 |
| low plateletsBlood and lymphatic system disorders | 2/7 | 2/4 |
| HypotensionInvestigations | 0/7 | 1/4 |
| skin reactionSkin and subcutaneous tissue disorders | 0/7 | 1/4 |
Traumatic Brain Injury
| Age, Continuous(years) | IV LCM | IV fPHT | Total |
|---|---|---|---|
| Median | 57 (38 to 66) | 55.5 (23 to 61) | 56 (23 to 66) |
| Sex: Female, Male(Participants) | IV LCM | IV fPHT | Total |
|---|---|---|---|
| Female | 3 | 0 | 3 |
| Male | 4 | 4 | 8 |
This study is terminated, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lacosamide
University of Alabama at Birmingham →