Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

NCT02409433 | Terminated Phase 4

• 1 other identifier: 100739
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

lacosamide; phenytoin

Outcome Measures

Primary Outcomes (1)

• Incidence of Clinical Adverse Events

  Safety: the primary outcome measure will be the incidence of clinical adverse events. Patients will be evaluated daily during the hospital stay for seizures, fever, neurological changes, cardiovascular, hematologic and dermatologic abnormalities, liver failure, renal failure, and death. Each adverse event will be classified by the principal investigator as attributable or possibly attributable to the study drug versus other events. Serious adverse events for these to study will be defined as those that result in death, prolonged hospitalization, life threatening events, persistent or significant disability, or an important medical event that may not be immediately life threatening or result in death but based upon appropriate medical judgment may jeopardize the participant, or may require medical or surgical intervention to prevent one of the other outcomes listed.

  6 months

Secondary Outcomes (1)

• Efficacy

  6 months

Study Arms (2)

lacosamide

EXPERIMENTAL

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

Drug: lacosamide

phenytoin

ACTIVE COMPARATOR

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.

Drug: Phenytoin

Interventions

lacosamide 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.

Also known as: Vimpat

lacosamide

Phenytoin 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.

Also known as: Dilantin

phenytoin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• UCB Pharma GmbH: collaborator

Study Sites (1)

University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Seizures

Interventions

Lacosamide; Phenytoin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; 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

Study Officials

• Jorge Burneo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 6, 2015
• Study Start: August 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 7, 2016

Record last verified: 2016-01

Locations

CA (1)