A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

NCT01110187 | Terminated Results DMC

• 1 other identifier: JPS-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Traumatic Brain Injury

Keywords

Lacosamide; Fosphenytoin; traumatic brain injury; Glasgow coma scale; Disability Rating Scale; Resource Utilization Questionnaire; Continuous EEG; seizures

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to 7 days

Secondary Outcomes (1)

• Number of Participants With Seizures

  baseline to 72 hours

Study Arms (2)

IV LCM (lacosamide)

EXPERIMENTAL

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

Drug: lacosamide

IV fPHT (fos-phenytoin)

ACTIVE COMPARATOR

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

Drug: Fosphenytoin

Interventions

lacosamide DRUG

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

IV LCM (lacosamide)

Fosphenytoin DRUG

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

IV fPHT (fos-phenytoin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• UCB Pharma: collaborator

Study Sites (3)

UC Health University Pointe

Cincinnati, Ohio, 45069, United States

Location

UC Health Medical Arts Building

Cincinnati, Ohio, 45219, United States

Location

University Hospital

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

• 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.

  PMID: 19898966 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Seizures

Interventions

Lacosamide; fosphenytoin; Phenytoin

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination due to lack of enrollment. Statistical comparisons between groups are not possible and were not performed.

Results Point of Contact

• Title: Jerzy P. Szaflarski, MD
• Organization: University of Alabama at Birmingham

szaflaj@uab.edu

205-934-3866

Study Officials

• Jerzy P Szaflarski, M.D., PhD

  Univeristy of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 26, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 28, 2014
• Results First Posted: April 28, 2014

Record last verified: 2014-02

Locations

US (3)