Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

NCT ID: NCT02409433

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-11-30

Brief Summary

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.

Conditions

Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

lacosamide

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

Group Type: EXPERIMENTAL

lacosamide

Intervention Type: DRUG

Comparison of patients treated with IV lacosamide to those treated with phenytoin in the intensive care unit setting.

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

phenytoin

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.

Group Type: ACTIVE_COMPARATOR

Phenytoin

Intervention Type: DRUG

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.

Interventions

lacosamide

Comparison of patients treated with IV lacosamide to those treated with phenytoin in the intensive care unit setting.

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

Intervention Type: DRUG

Phenytoin

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.

Intervention Type: DRUG

Other Intervention Names

Vimpat; Dilantin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma GmbH

INDUSTRY

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Jorge Burneo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jorge Burneo, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

University Hospital

London, Ontario, Canada

Countries

Canada

Other Identifiers

100739

Identifier Type: -

Identifier Source: org_study_id