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Levetiracetam, Lacosamide and Ketamine as Adjunctive Treatment of Refractory Status Epilepticus

NCT02726867 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-08-29

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of levetiracetam , lacosamide and ketamine treatment of refractory status epilepticus. This will be a randomized, open-label, four-arm pilot study comparing time to cessation of refractory status epilepticus, determined by continuous EEG monitoring, in patients with refractory status epilepticus. Patients with status epilepticus who have been treated with standard dose lorazepam (or midazolam) and ≥ 1000 mg phenytoin with documented levels of ≥20 mg/ml and continue to have clinical status epilepticus for ≥1-24 hours after phenytoin loading will receive intravenously (i.v.) either 4000 mg levetiracetam, 600 mg lacosamide (Group B), 2.5 mg/kg ketamine or phenobarbital 15 mg/kg phenobarbital (Group D)

Conditions

Interventions

DRUG

levetiracetam

Treatment will consist of LEV 4000 mg i.v. over 10 minutes.

DRUG

lacosamide

Treatment will consist of LCM 600 mg i.v. over 10 minutes

DRUG

Ketamine

Treatment will consist of KET 2.5 mg/kg over 10 minutes

DRUG

Phenobarbital

Treatment will consist of PHB 15 mg/kg mg i.v. at 100 mg/minute rate

Sponsors & Collaborators

  • Mid-Atlantic Epilepsy and Sleep Center, LLC

    lead OTHER

Principal Investigators

  • Pavel Klein, M.D. · Mid-Atlantic Epilepsy and Sleep Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02726867 on ClinicalTrials.gov