Status:
COMPLETED
Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures
Lead Sponsor:
Aatif Husain
Collaborating Sponsors:
UCB Pharma
Conditions:
Nonconvulsive Seizures
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This a phase 2 study comparing the efficacy of intravenous (IV) lacosamide (LCM) with IV fosphenytoin (fPHT) in controlling frequent nonconvulsive seizures (NCSs), the Adverse Events profile of LCM co...
Detailed Description
Exploratory, prospective, multicenter, open-label, randomized study, in which the physicians who are interpreting cEEGs for treatment purposes and the central reviewers who are providing final cEEG in...
Eligibility Criteria
Inclusion
- Have the capacity to understand and sign an institutional review board (IRB)-approved informed consent form (ICF) or have a legally authorized representative (LAR) available to sign on behalf of the subject.
- Are undergoing cEEG monitoring in the neurologic intensive care unit (NICU) or other closely monitored environment.
- Are experiencing NCSs according to the following criteria:
- At least 1 ESz lasting at least 10 seconds, with or without clinical correlates, occurring within the last 6 hours of cEEG monitoring.
- If a new AED has been started, ESzs must have occurred per the preceding bullet point at least 2 hours after starting that AED.
- If individual ESzs are not well defined, ESz time is at least 10 seconds and less than 30 minutes per hour of cEEG recording.
- Are being considered for treatment with an IV AED.
- Are at least 18 years old.
Exclusion
- Treatment with PHT, fPHT, or LCM in the last 7 days.
- Contraindication for the use of fPHT or LCM.
- Ongoing generalized convulsive status epilepticus (SE) (more than 2 generalized tonic-clonic seizures within 30 minutes without recovery to baseline or 1 seizure lasting longer than 10 minutes).
- Episodes of SE, defined as at least 30 minutes of ESz activity in 1 hour, in the last 6 hours.
- Encephalopathic event secondary to acute anoxic/hypoxic event.
- Undergoing therapeutic hypothermia protocol.
- Continuous EEG monitoring showing only periodic discharges or rhythmic delta activity without clear ESzs (for definitions of periodic discharges, rhythmic delta activity, and ESzs, see the Manual of Operations).
- Electroencephalographic seizures consistent with typical absence seizures.
- Evaluation for spell characterization or surgical treatment for epilepsy.
- Pregnancy.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01458522
Start Date
May 1 2012
End Date
July 1 2015
Last Update
June 11 2018
Active Locations (11)
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1
Huntington Memorial Hospital
Pasadena, California, United States, 91109
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30307
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214