Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

Lawson Health Research Institute

Status and phase: Terminated; Phase 4

Conditions: Seizures

Treatments: Drug: lacosamide; Drug: Phenytoin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02409433

100739

Details and patient eligibility

About

The Investigator plans to perform a prospective, randomized, single blinded, study that will compare patients treated with IV lacosamide to those treated with Phenytoin in the Intensive Care Unit (ICU) setting. The investigator will also evaluate the rate of clinically evident and sub-clinical seizures, and to compare long-term outcomes between patients treated with lacosamide and those treated with Phenytoin.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Traumatic Brain Injury (TBI) or Subarachnoid hemorrhage (SAH)
• Admitted to the hospital less than 48 hours prior to randomization
• Glasgow Coma Scale (GCS) score 3-8 (inclusive), or GCS motor score of five or less and abnormal CT scan showing intracranial pathology
• Hemodynamically stable
• Older than 18 years of age

Exclusion criteria

• No IV access
• Spinal cord injury
• History of or CT confirmation of previous brain injury, including brain tumor, stroke, or a spontaneous intracerebral hemorrhage
• Hemodynamically unstable
• Suspected anoxia
• Liver failure
• Younger than 18 years of age
• Pregnant
• Allergy to phenytoin or lacosamide
• Inability to obtain consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

3 participants in 2 patient groups

lacosamide

Experimental group

Description:

The lacosamide group will receive a loading dose of 400 mg IV, and on maintenance dose of up to 400 mg every 12 hours.

Treatment:

Drug: lacosamide

phenytoin

Active Comparator group

Description:

the phenytoin group will receive a loading dose of 20 mg/K IV, maximum of 2000 mg, given over 60 min. and will be started on a maintenance dose of 5 mg/K/day. Levels will be checked accordingly.

Treatment:

Drug: Phenytoin