Nonconvulsive Seizures
Conditions
Keywords
Nonconvulsive Seizures
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 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.
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 interpretation for study purposes are all blinded to treatment. Initial LCM/maintenance doses: Subjects will receive a 400-mg IV initial bolus over 30 minutes, followed by a 2-hour post-dose observation-only period. If a breakthrough seizure occurs in the 6 hours following the 2-hour post-dose observation-only period, the subject will receive a 200-mg rebolus over 30 minutes. Regardless of whether a rebolus was administered, a maintenance dose of LCM will be started 12 hours after the initial bolus, and it will continue every 12 hours throughout the acute-treatment period. The daily maintenance dose will be equivalent to the total IV bolus per day (400 mg if no rebolus was administered or 600 mg if a rebolus was administered), divided into 2 doses. After completion of the acute-treatment period, daily maintenance with an AED will be at the discretion of the treating physician. Initial fPHT/maintenance doses: Subjects will receive a 20-mg PE/kg IV initial bolus at a rate no greater than 75 mg PE/minute, followed by a 2-hour post-dose observation-only period. If a breakthrough seizure occurs in the 6 hours following the 2-hour post-dose observation-only period, the subject will receive a 5-mg PE/kg IV rebolus at a rate no greater than 75 mg PE/minute. Regardless of whether a rebolus was administered, a maintenance dose of fPHT will be started 12 hours after the initial bolus, and it will continue every 12 hours throughout the acute-treatment period. The daily maintenance dose will be 5 mg PE/kg, divided into 2 doses. After completion of the acute-treatment period, daily maintenance with an AED will be at the discretion of the treating physician. Crossover/maintenance doses: If a subject does not receive a rebolus but has a seizure within 24 hours following the 2-hour post-initial-dose observation-only period, he or she will cross over and begin receiving the other drug, ie, the one not originally administered. If a subject does receive a rebolus and has another seizure within 24 hours following the 2-hour post-rebolus observation-only period, he or she will also cross over to the other drug. If crossover occurs, the subject will start over with the second drug, going through the same observation-only period and rebolusing, if necessary. If a subject crosses over and starts receiving the second drug, in addition to receiving every-12-hours maintenance doses of the drug originally administered, the subject will also receive maintenance doses of the second drug every 12 hours, beginning 12 hours after the first dose of the second drug.
Interventions
DRUGfPHT
If after initial treatment with fPHT any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug. If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments.
DRUGLCM
If after initial treatment with LCM any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug. If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments.
Sponsors
UCB Pharma
Aatif Husain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Are undergoing cEEG monitoring in the neurologic intensive care unit (NICU) or other closely monitored environment. 3. 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. 4. Are being considered for treatment with an IV AED. 5. Are at least 18 years old.
Exclusion criteria
1. Treatment with PHT, fPHT, or LCM in the last 7 days. 2. Contraindication for the use of fPHT or LCM. 3. 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). 4. Episodes of SE, defined as at least 30 minutes of ESz activity in 1 hour, in the last 6 hours. 5. Encephalopathic event secondary to acute anoxic/hypoxic event. 6. Undergoing therapeutic hypothermia protocol. 7. 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). 8. Electroencephalographic seizures consistent with typical absence seizures. 9. Evaluation for spell characterization or surgical treatment for epilepsy. 10. Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 24 hours | Percentage of subjects who experience no nonconvulsive seizures (NCS) for 24 hours (after the 2-hour observation-only period) following treatment with LCM vs. fPHT, as measured by continuous electroencephalography (cEEG) monitoring with blinded review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Require a Rebolus of the Initial Antiepileptic Drugs (AED) to Control Nonconvulsive Seizures (NCS) in the LCM vs fPHT Arms. | 24 hours | The percentage of subjects who require a rebolus of the initial antiepileptic drug (AED) to control nonconvulsive seizures (NCS) in the LCM vs fPHT arms. |
| Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS) | 24-26 hours | Number of subjects who required a second antiepileptic drug (AED) to control nonconvulsive seizures (NCS) |
| Seizure Burden Change From Baseline to End of Initial Treatment | Baseline, 24 hours | Absolute change in seizure time (defined as the number of minutes of electrographic seizure (ESz) activity per hour) before treatment and at the end of the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour. The maximum amount of time that can be used to determine baseline seizure time is 6 hours. |
| Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm | baseline, 26-68 hours | Absolute change defined as the number of minutes of ESz activity per hour before treatment and at the end of the second treatment arm. This measure does not evaluate seizure activity in the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour. |
| Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1 | baseline to end of treatment arm 1 | Percentage of subjects in whom study drug is withdrawn early after treatment with treatment arm 1 |
| Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration | 24 hours | Number of predefined adverse events (AE) after treatment arm 1 administration. These predefined adverse events include Patients with at least one AE of interest, Cardiac disorders, investigations, suspected hypersensitivity reactions, vascular disorders, and hypotension. |
| Days in the Intensive Care Unit/Hospital | initial bolus to end of study | Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in more days of hospitalization than the other over the course of the study. |
| 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. | Baseline to day 7-9, baseline to day 30 | Change in functional status as measured by the Functional Disability Scale, using a 0-29 rating (0=w/o disability; 29=extreme vegetative state) at Day 7 to 9 postrandomization and Day 30 post-randomization in the LCM first, then fPHT versus fPHT first, then LCM arms. Data was analyzed in a manner consistent with determining if one treatment arm resulted in a greater change in functional status than the other. |
| Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30 | both acute treatment periods to 30 days | Percentage of all subjects who have had a seizure, are on antiepileptic drug (AED) therapy, and are alive and dead at day 30. Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in a greater effect on seizures, antiepileptic drug (AED) use, and survival at day 30 after the acute treatment period. The acute treatment period could range from 6 to 30 hours. |
| Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm | time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm | Time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm |
Countries
United States
Participant flow
Recruitment details
173 participants consented. 74 participants were randomized.
Pre-assignment details
37 participants randomized to LCM, however 2 participants did not receive drug. 37 participants were randomized to fPHT and everyone received drug.
Participants by arm
| Arm | Count |
|---|---|
| LCM First, Then fPHT LCM treatment arm, a bolus of 400 mg will be administered over 30 minutes. If a further bolus is required, 200 mg will be administered. Regardless of whether the subject received a rebolus, he or she will begin receiving a maintenance dose 12 hours after the initial dose. The daily maintenance dose will be the same as the total bolus (400 mg or 600 mg) divided into 2 doses.
If after initial treatment and any of the following occurs, subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.
Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.
Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.
Subject experiences an AE that precludes further use of the first study drug.
If crossover occurs, the subject will start over with the second drug, going through the same observation-only period. | 37 |
| fPHT First, Then LCM fPHT treatment arm, a bolus of 20 mg PE/kg will be administered at a rate of no greater than 75 mg PE/minute. If a further bolus is required, 5 mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5 mg PE/kg divided into 2 doses.
If after initial treatment and any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug.
Subject has another seizure within 24 hours following the 2-hour post-rebolus observation-only period.
Subject dose not receive a rebolus but has a seizure within 24 hours following 2-hour post bolus observation-only period.
Subject experiences an AE that precludes further use of the first study drug.
If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary). | 37 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 9 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | fPHT First, Then LCM | LCM First, Then fPHT | Total |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 20.4 | 63.8 years STANDARD_DEVIATION 12.1 | 63.6 years STANDARD_DEVIATION 16.6 |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 9 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 32 Participants | 26 Participants | 58 Participants |
| Region of Enrollment United States | 37 Participants | 37 Participants | 74 Participants |
| Sex: Female, Male Female | 21 Participants | 17 Participants | 38 Participants |
| Sex: Female, Male Male | 16 Participants | 20 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 45 | 8 / 50 |
| other Total, other adverse events | 22 / 45 | 27 / 50 |
| serious Total, serious adverse events | 10 / 45 | 13 / 50 |
Outcome results
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.
Percentage of subjects who experience no nonconvulsive seizures (NCS) for 24 hours (after the 2-hour observation-only period) following treatment with LCM vs. fPHT, as measured by continuous electroencephalography (cEEG) monitoring with blinded review.
Time frame: 24 hours
Population: Data are reported for the percentage of participants without a nonconvulsive seizure event in the period prior to crossover.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LCM 400mg | 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 Participants |
| fPHT 20mg PE/kg | 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. | 22 Participants |
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.
Change in functional status as measured by the Functional Disability Scale, using a 0-29 rating (0=w/o disability; 29=extreme vegetative state) at Day 7 to 9 postrandomization and Day 30 post-randomization in the LCM first, then fPHT versus fPHT first, then LCM arms. Data was analyzed in a manner consistent with determining if one treatment arm resulted in a greater change in functional status than the other.
Time frame: Baseline to day 7-9, baseline to day 30
Population: participants who completed the Functional Disability Scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LCM 400mg | 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. | Change from baseline to day 7-9 | -4.1 units on a scale | Standard Deviation 7.64 |
| LCM 400mg | 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. | Change from baseline to day 30 | -8.5 units on a scale | Standard Deviation 11.73 |
| fPHT 20mg PE/kg | 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. | Change from baseline to day 7-9 | 0.3 units on a scale | Standard Deviation 4.52 |
| fPHT 20mg PE/kg | 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. | Change from baseline to day 30 | -3.7 units on a scale | Standard Deviation 5.01 |
Secondary
Days in the Intensive Care Unit/Hospital
Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in more days of hospitalization than the other over the course of the study.
Time frame: initial bolus to end of study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LCM 400mg | Days in the Intensive Care Unit/Hospital | Days in ICU | 7.4 days | Standard Deviation 8.36 |
| LCM 400mg | Days in the Intensive Care Unit/Hospital | Days in hospital | 12.7 days | Standard Deviation 7.63 |
| fPHT 20mg PE/kg | Days in the Intensive Care Unit/Hospital | Days in ICU | 6.5 days | Standard Deviation 8.73 |
| fPHT 20mg PE/kg | Days in the Intensive Care Unit/Hospital | Days in hospital | 12.5 days | Standard Deviation 10.03 |
Secondary
Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration
Number of predefined adverse events (AE) after treatment arm 1 administration. These predefined adverse events include Patients with at least one AE of interest, Cardiac disorders, investigations, suspected hypersensitivity reactions, vascular disorders, and hypotension.
Time frame: 24 hours
Population: Patients who received treatment arm 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LCM 400mg | Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration | 4 Number of predefined AEs |
| fPHT 20mg PE/kg | Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration | 5 Number of predefined AEs |
Secondary
Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS)
Number of subjects who required a second antiepileptic drug (AED) to control nonconvulsive seizures (NCS)
Time frame: 24-26 hours
Population: Participants who crossed over to second drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LCM 400mg | Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS) | 15 Participants |
| fPHT 20mg PE/kg | Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS) | 10 Participants |
Secondary
Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30
Percentage of all subjects who have had a seizure, are on antiepileptic drug (AED) therapy, and are alive and dead at day 30. Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in a greater effect on seizures, antiepileptic drug (AED) use, and survival at day 30 after the acute treatment period. The acute treatment period could range from 6 to 30 hours.
Time frame: both acute treatment periods to 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LCM 400mg | Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30 | any seizure within 30 days after acute tx period | 27.4 percentage of participants |
| LCM 400mg | Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30 | AED use within 30 days after acute tx period | 82.2 percentage of participants |
| LCM 400mg | Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30 | Died within 30 days after randomization | 15.5 percentage of participants |
| fPHT 20mg PE/kg | Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30 | any seizure within 30 days after acute tx period | 38.9 percentage of participants |
| fPHT 20mg PE/kg | Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30 | AED use within 30 days after acute tx period | 74.0 percentage of participants |
| fPHT 20mg PE/kg | Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30 | Died within 30 days after randomization | 16.0 percentage of participants |
Secondary
Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1
Percentage of subjects in whom study drug is withdrawn early after treatment with treatment arm 1
Time frame: baseline to end of treatment arm 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LCM 400mg | Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1 | 2 Participants |
| fPHT 20mg PE/kg | Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1 | 3 Participants |
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.
The percentage of subjects who require a rebolus of the initial antiepileptic drug (AED) to control nonconvulsive seizures (NCS) in the LCM vs fPHT arms.
Time frame: 24 hours
Population: Data are reported for the percentage of participants who require a rebolus of the initial antiepileptic drugs (AED) to control nonconvulsive seizures (NCS) in the LCM vs fPHT arms in the period prior to crossover.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LCM 400mg | 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 Participants |
| fPHT 20mg PE/kg | Percentage of Subjects Who Require a Rebolus of the Initial Antiepileptic Drugs (AED) to Control Nonconvulsive Seizures (NCS) in the LCM vs fPHT Arms. | 13 Participants |
Secondary
Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm
Absolute change defined as the number of minutes of ESz activity per hour before treatment and at the end of the second treatment arm. This measure does not evaluate seizure activity in the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour.
Time frame: baseline, 26-68 hours
Population: participants who had satisfactory EEG data (sometimes EEG leads would come off)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LCM 400mg | Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm | -0.78 min/hour | Standard Deviation 0.486 |
| fPHT 20mg PE/kg | Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm | -0.83 min/hour | Standard Deviation 0.346 |
Secondary
Seizure Burden Change From Baseline to End of Initial Treatment
Absolute change in seizure time (defined as the number of minutes of electrographic seizure (ESz) activity per hour) before treatment and at the end of the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour. The maximum amount of time that can be used to determine baseline seizure time is 6 hours.
Time frame: Baseline, 24 hours
Population: Participants who had satisfactory EEG data (sometimes EEG leads would come off)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LCM 400mg | Seizure Burden Change From Baseline to End of Initial Treatment | -0.58 min/hour | Standard Deviation 0.95 |
| fPHT 20mg PE/kg | Seizure Burden Change From Baseline to End of Initial Treatment | -0.54 min/hour | Standard Deviation 0.828 |
p-value: 0.512Poisson regression model
Secondary
Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm
Time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm
Time frame: time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm
Population: participants who had satisfactory EEG data (sometimes EEG leads would come off)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LCM 400mg | Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm | Crossover Treatment | 8.2 hours | Standard Deviation 11.05 |
| LCM 400mg | Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm | Initial Treatment | 8.4 hours | Standard Deviation 13.08 |
| fPHT 20mg PE/kg | Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm | Crossover Treatment | 1.7 hours | Standard Deviation 3.46 |
| fPHT 20mg PE/kg | Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm | Initial Treatment | 9.8 hours | Standard Deviation 11.84 |