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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00037794 | Other Identifier | Duke Site Protocol Number | |
| DCRI-CEMC101.01 |
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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fPHT 20mg | Active Comparator | 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. |
|
| LCM 400mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fPHT | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
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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:
Are being considered for treatment with an IV AED.
Are at least 18 years old.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aatif Husain, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Memorial Hospital | Pasadena | California | 91109 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23953988 | Derived | Belcastro V, Vidale S, Pierguidi L, Sironi L, Tancredi L, Striano P, Taborelli A, Arnaboldi M. Intravenous lacosamide as treatment option in post-stroke non convulsive status epilepticus in the elderly: a proof-of-concept, observational study. Seizure. 2013 Dec;22(10):905-7. doi: 10.1016/j.seizure.2013.07.011. Epub 2013 Aug 13. |
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37 participants randomized to LCM, however 2 participants did not receive drug. 37 participants were randomized to fPHT and everyone received drug.
173 participants consented. 74 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | LCM First, Then fPHT | LCM bolus of 400 mg administered over 30 minutes. If further bolus is required, 200 mg is administered. Regardless of whether the subject received a rebolus, they will begin receiving a maintenance dose 12 hrs after initial dose. 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 end of 1st treatment arm and will crossover and receive the other drug. If any of the following did not occur the subject will be considered completed. Subject has another seizure within 24 hrs following the 2-hr post-rebolus observation-only period. Subject dose not receive a rebolus but has a seizure within 24 hrs following 2-hr post bolus observation-only period. Subject experiences an AE that precludes further use of the 1st study drug. If crossover occurs, the subject will start over with the second drug, going through the same observation-only period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| LCM | Drug | 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. |
|
|
| 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) |
| 24-26 hours |
| 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. | Baseline, 24 hours |
| 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. | baseline, 26-68 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 |
| 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. | 24 hours |
| 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 | baseline to end of treatment arm 1 |
| 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. | initial bolus to end of 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. | 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. | Baseline to day 7-9, baseline to day 30 |
| 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. | both acute treatment periods to 30 days |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Emory University School of Medicine | Atlanta | Georgia | 30307 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Brigham and Woman's Hospital | Boston | Massachusetts | 02215 | United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center Dallas | Dallas | Texas | 75390-8589 | United States |
| FG001 | 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. If any of the following did NOT occur the subject will be considered completed. 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). |
| Received First Drug |
|
| Crossover to Second Drug |
|
| COMPLETED | Completed all assigned intervention & observation. Not all subjects were assigned to crossover. |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data are reported for the percentage of participants without a nonconvulsive seizure event in the period prior to crossover. | Posted | Count of Participants | Participants | 24 hours |
|
|
| |||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | 24 hours |
| |||||||||||||||||||||||||||||||
| 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) | Participants who crossed over to second drug | Posted | Count of Participants | Participants | 24-26 hours |
| |||||||||||||||||||||||||||||||
| 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. | Participants who had satisfactory EEG data (sometimes EEG leads would come off) | Posted | Mean | Standard Deviation | min/hour | Baseline, 24 hours |
| ||||||||||||||||||||||||||||||
| 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. | participants who had satisfactory EEG data (sometimes EEG leads would come off) | Posted | Mean | Standard Deviation | min/hour | baseline, 26-68 hours |
| ||||||||||||||||||||||||||||||
| 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 | participants who had satisfactory EEG data (sometimes EEG leads would come off) | Posted | Mean | Standard Deviation | hours | time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm |
| ||||||||||||||||||||||||||||||
| 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. | Patients who received treatment arm 1 | Posted | Number | Number of predefined AEs | 24 hours |
|
| ||||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | baseline to end of treatment arm 1 |
| ||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | days | initial bolus to end of study |
| |||||||||||||||||||||||||||||||
| 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. | participants who completed the Functional Disability Scale | Posted | Mean | Standard Deviation | units on a scale | Baseline to day 7-9, baseline to day 30 |
| ||||||||||||||||||||||||||||||
| 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. | Posted | Number | percentage of participants | both acute treatment periods to 30 days |
|
Adverse event data was collected for 30 days after last dose of study drug (approximately 30-32 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants Receiving LCM 400mg | Participants who receive a bolus of 400mg administered over 30 minutes. If a further bolus is required, 200mg 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 (400mg or 600mg) divided into 2 doses. | 7 | 45 | 10 | 45 | 22 | 45 |
| EG001 | All Participants Receiving fPHT 20mg PE/kg | Participants who receive a bolus of 20mg PE/kg administered at a rate no greater than 75mg PE/minute. If a further bolus is required, 5mg PE/kg will be administered. The daily maintenance dose for fPHT will be 5mg PE/kg divided into 2 doses. | 8 | 50 | 13 | 50 | 27 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Herpes simplex encephalitis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Subdural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Toxicity to various agents | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cerebral hemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Neurological decompensation | Nervous system disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Encephalitis viral | Infections and infestations | Systematic Assessment |
| ||
| Grand mal convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhagic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial pressure increased | Nervous system disorders | Systematic Assessment |
| ||
| respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Herpes simplex encephalitis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Subdural haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incorrect route of drug administration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Toxicity to various agents | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Heart rate abnormal | Investigations | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Neurological decompensation | Nervous system disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| hypotension | Vascular disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infusion site extravasation | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Encephalitis viral | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Grand mal convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhagic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial pressure increased | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aatif M. Husain, M.D. | Duke University | 919-668-8700 | aatif.husain@duke.edu |
| ID | Term |
|---|---|
| C043114 | fosphenytoin |
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
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| Male |
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| Black or African American |
|
| Asian |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|
| Participants |
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| 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). |
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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). |
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| OG001 | 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). |
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| OG001 |
| 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). |
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