Phase 2
N=74
Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures
Nonconvulsive Seizures
Bottom Line
View on ClinicalTrials.gov: NCT01458522 ↗Enrolled (actual)
74
Serious AEs
24.2%
Results posted
Jun 2018
Primary outcome: Primary: Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring. — 19; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fPHT (Drug); LCM (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aatif Husain
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring. |
19; 22 | — |
| SECONDARY Percentage of Subjects Who Require a Rebolus of the Initial Antiepileptic Drugs (AED) to Control Nonconvulsive Seizures (NCS) in the LCM vs fPHT Arms. |
16; 13 | — |
| SECONDARY Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS) |
15; 10 | — |
| SECONDARY Seizure Burden Change From Baseline to End of Initial Treatment |
-0.58; -0.54 | 0.512 |
| SECONDARY Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm |
-0.78; -0.83 | — |
| SECONDARY Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm |
8.4; 9.8; 8.2; 1.7 | — |
| SECONDARY Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration |
4; 5 | — |
| SECONDARY Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1 |
2; 3 | — |
| SECONDARY Days in the Intensive Care Unit/Hospital |
7.4; 6.5; 12.7; 12.5 | — |
| SECONDARY Change in Functional Status as Measured by the Functional Disability Scale at Day 7 to 9 Postrandomization and Day 30 Post-randomization in the LCM vs fPHT Arms. |
-4.1; 0.3; -8.5; -3.7 | — |
| SECONDARY Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30 |
27.4; 38.9; 82.2; 74.0; 15.5; 16.0 | — |
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 compared with fPHT when used to treat frequent NCSs, and length of stay in an intensive care unit for subjects treated with LCM versus subjects treated with fPHT. The trial will include a preacute-treatment period, an acute-treatment period, a postacute-treatment period, and a long-term follow-up period.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01458522). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.