Traumatic Brain InjuryNCT01110187
A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
A study testing lacosamide and Fosphenytoin in people with Traumatic Brain Injury, run by University of Alabama at Birmingham at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- lacosamide and Fosphenytoin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UC Health University Pointe
Cincinnati, Ohio, 45069
UC Health Medical Arts Building
Cincinnati, Ohio, 45219
University Hospital
Cincinnati, Ohio, 45219
About this study
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.
Read the 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
- Conditions
- Traumatic Brain Injury
- Being tested
- lacosamide, Fosphenytoin
- Keywords
- Lacosamide, Fosphenytoin, traumatic brain injury, Glasgow coma scale, Disability Rating Scale, Resource Utilization Questionnaire, Continuous EEG, seizures
- Medical subject headings
- Brain Injuries, Traumatic, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lacosamideDrug
Also called Vimpat
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.
FosphenytoinDrug
Also called Dilantin
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
| Study group | Role | What they receive |
|---|---|---|
| IV LCM (lacosamide) | Experimental | Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide. Receives: Drug: lacosamide |
| IV fPHT (fos-phenytoin) | Active comparator | Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin Receives: Drug: Fosphenytoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 7 days
Secondary outcomes (1)
Number of Participants With Seizures
Number of seizures in the first 72 hours based on EEG recording
Measured: baseline to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Lack of enrollement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Principal investigator, Jerzy P Szaflarski, University of Alabama at Birmingham
- Investigators
- Jerzy P Szaflarski, M.D., PhD, Principal investigator, Univeristy of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110187
- Sponsor's protocol ID
- JPS-001
- Status last verified
- Feb 2014
- First submitted
- 16 Apr 2010
- Last updated
- 28 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19898966
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
- ClinicalTrials.gov ID
- NCT01110187
- Acronym / sponsor ID
- JPS-001
- Conditions
- Traumatic Brain Injury
- Keywords
- Lacosamide, Fosphenytoin, traumatic brain injury, Glasgow coma scale, Disability Rating Scale, Resource Utilization Questionnaire, Continuous EEG, seizures
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollement
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Posted 28 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV LCM (lacosamide) | Experimental | Drug: lacosamidePatients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide. |
| IV fPHT (fos-phenytoin) | Active comparator | Drug: FosphenytoinPatients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lacosamideAlso: Vimpat200 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. | Drug | IV LCM (lacosamide) |
| FosphenytoinAlso: Dilantin20 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 | Drug | IV fPHT (fos-phenytoin) |
Primary outcome
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.
1 secondary outcome
Number of Participants With Seizures
Time frame: baseline to 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19898966Szaflarski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerzy P Szaflarski, M.D., PhD principal investigator
Univeristy of Cincinnati
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lacosamide and Fosphenytoin in people with Traumatic Brain Injury, run by University of Alabama at Birmingham at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: baseline to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01110187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014.