Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465244
Status:
WITHDRAWN
Last Update Posted:
2012-11-01
First Post:
2007-04-23
Brief Title:
Seizure Therapy With Intravenous Levetiracetam and Lorazepam
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Seizure Therapy With Intravenous Levetiracetam and Lorazepam
Status:
WITHDRAWN
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to recruit subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STILL
Brief Summary:
The overarching aim of STILL is assessment of IV LEV in the management of seizures in the ED setting The main study endpoints are considered in the two patient groups of interest SE and non-SE
For non-SE patients STILL will compare IV LEV vs the current standard-care of placebo with respect to the following questions
Does IV LEV administration result in lower seizure duration andor recurrence rate than does administration of placebo Ho No difference in seizure duration or recurrence rates between the two groups
Is IV LEV associated with a different rate of significant side effects than placebo Ho No difference in significant side effect rates between the two groups
For SE patients STILL will compare IV LEV lorazepam 2mg vs lorazepam 3 mg with respect to the following questions
Does addition of IV LEV to a BZD allow for a BZD-sparing effect ie achievement of seizure control with lower dose of BZD Ho No difference in seizure duration andor recurrence rates between the two groups
Is IV LEV lower-dose BZD associated with a different rate of significant side effects than the higher-dose BZD administered as monotherapy Ho No difference in significant side effect rates between the two groups
For non-SE patients STILL will compare IV LEV vs the current standard-care of placebo with respect to the following questions
Does IV LEV administration result in lower seizure duration andor recurrence rate than does administration of placebo Ho No difference in seizure duration or recurrence rates between the two groups
Is IV LEV associated with a different rate of significant side effects than placebo Ho No difference in significant side effect rates between the two groups
For SE patients STILL will compare IV LEV lorazepam 2mg vs lorazepam 3 mg with respect to the following questions
Does addition of IV LEV to a BZD allow for a BZD-sparing effect ie achievement of seizure control with lower dose of BZD Ho No difference in seizure duration andor recurrence rates between the two groups
Is IV LEV lower-dose BZD associated with a different rate of significant side effects than the higher-dose BZD administered as monotherapy Ho No difference in significant side effect rates between the two groups
Detailed Description:
The study will enroll adults age at least 18 years in the EDs of MGH or BWH Patients will be classified depending upon their clinical presentation into the SE group or the non-SE group The total enrollment projected for non-SE patients is 150 the total enrollment projected for SE patients is 200 It is expected that at least 3 years may be required to enroll the requisite number of patients
Patients are eligible for study enrollment if they have had a seizure and if they do not have known pregnancy or renal failure and if they are not known to be breastfeeding Hypotension is the only other exclusion criteria for the study There are no other contraindications to study enrollment
Patients evaluated at the MGHBWH EDs for seizures may arrive by private vehicle or ambulance A STILL pager will be activated by ED physicians upon notification of impending ambulance arrival with a suspected seizure patient SE or non-SE the pager can also be activated after patient arrival at the ED by ambulance or private vehicle
Upon patient arrival to the ED standard stabilization will be provided If the patient is determined to have had a seizure or if the patient is currently seizing an IV will be placed if not already present in line with standard ED care For the patient to be eligible for STILL the seizure must have occurred within an hour of ED arrival
Care providers will make a determination as to whether patients are eligible using a checklist readily available in the ED For patients who are determined to be eligible the care providers will indicate whether patients are in the SE or non-SE arm - the study groups are hereafter denoted SE and non-SE
STILL medications will be stored in the ED with other medications so that they are readily available to care providers The STILL medications will be in a separate section of the automated drug dispenser units in the ED STILL medications will be subdivided as to whether patients are in the SE or non-SE arms In each of the two subsections SE and non-SE of the EDs automated drug dispensers will be one box of study medications Thus the ED will always have on hand sufficient study medications to enroll one patient in either the SE or non-SE arm The randomization procedures to determine the contents of the study medication boxes will be done in the Research Pharmacy so no randomization needs to occur prior to treatment in the ED The study boxes will have unique identifier numbers which will then be reported back to the Research Pharmacy after the study medications have been administered the Research Pharmacy thus will have track of which study patients received which study boxes and which medication regimens This approach to patient allocation and drug dispensing and tracking is consistent with current mechanisms for enrolling patients in Partners IRB-approved studies in the MGHBWH EDs
Inside the SE partition in the ED box will be a syringe containing lorazepam concentration 2 mgmL in either a 2 mg or 3 mg dose an extra volume of inactive diluent will be added to the 2 mg dose so that the volume 15 mL is that same in each syringe In a manner consistent with previousongoing Partners IRB-approved studies in the ED the syringe will be labeled lorazepam - 2mg or 3mg Also in the SE compartment of the drug dispenser will be an infusion set labeled levetiracetam 15g or placebo Thus for SE patients care providers will administer two agents from the medication dispenser patients will receive either lorazepam 2mg levetiracetam 15 g or lorazepam 3mg placebo Care providers will be instructed by information included with the study drugs to administer the lorazepam over 15-2 minutes this is in line with standard recommendations that lorazepam be administered at a rate not to exceed 2 mgmin28 38 The infusion ie levetiracetam or placebo will be administered over 5 minutes
Inside the non-SE partition in the ED box will be an infusion set labeled levetiracetam 15g or placebo Thus for non-SE patients care providers will administer one agent from the medication dispenser patients will receive either levetiracetam 15 g or placebo Care providers will be instructed by information included with the study drugs to administer the infusion over 5 minutes
The contents of the partitions in the ED drug dispenser will be determined in advance by a randomization scheme that prevents the need for care providers to make a phone call or otherwise spend time which they do not have randomizing patients When the EDs use study drug from either arm of STILL they will contact the Research Pharmacy which will replace the used materials and note the patients medical record number along with the true identity of the study agents administered
Any adjunctive medication may be administered at the discretion of the treating physicians
Study endpoints for SE and non-SE patients are outlined in the Detailed Protocol Briefly SE analysis will focus on whether seizure recurrence is reduced and whether respiratory depression and other post-medication vital signs changes occur less frequently in patients receiving LEV and the smaller dose of lorazepam as compared to those receiving the higher-dose lorazepam alone For non-SE patients endpoints will include seizure recurrence as well as quality of the examination and occurrence of side effects
Patients are eligible for study enrollment if they have had a seizure and if they do not have known pregnancy or renal failure and if they are not known to be breastfeeding Hypotension is the only other exclusion criteria for the study There are no other contraindications to study enrollment
Patients evaluated at the MGHBWH EDs for seizures may arrive by private vehicle or ambulance A STILL pager will be activated by ED physicians upon notification of impending ambulance arrival with a suspected seizure patient SE or non-SE the pager can also be activated after patient arrival at the ED by ambulance or private vehicle
Upon patient arrival to the ED standard stabilization will be provided If the patient is determined to have had a seizure or if the patient is currently seizing an IV will be placed if not already present in line with standard ED care For the patient to be eligible for STILL the seizure must have occurred within an hour of ED arrival
Care providers will make a determination as to whether patients are eligible using a checklist readily available in the ED For patients who are determined to be eligible the care providers will indicate whether patients are in the SE or non-SE arm - the study groups are hereafter denoted SE and non-SE
STILL medications will be stored in the ED with other medications so that they are readily available to care providers The STILL medications will be in a separate section of the automated drug dispenser units in the ED STILL medications will be subdivided as to whether patients are in the SE or non-SE arms In each of the two subsections SE and non-SE of the EDs automated drug dispensers will be one box of study medications Thus the ED will always have on hand sufficient study medications to enroll one patient in either the SE or non-SE arm The randomization procedures to determine the contents of the study medication boxes will be done in the Research Pharmacy so no randomization needs to occur prior to treatment in the ED The study boxes will have unique identifier numbers which will then be reported back to the Research Pharmacy after the study medications have been administered the Research Pharmacy thus will have track of which study patients received which study boxes and which medication regimens This approach to patient allocation and drug dispensing and tracking is consistent with current mechanisms for enrolling patients in Partners IRB-approved studies in the MGHBWH EDs
Inside the SE partition in the ED box will be a syringe containing lorazepam concentration 2 mgmL in either a 2 mg or 3 mg dose an extra volume of inactive diluent will be added to the 2 mg dose so that the volume 15 mL is that same in each syringe In a manner consistent with previousongoing Partners IRB-approved studies in the ED the syringe will be labeled lorazepam - 2mg or 3mg Also in the SE compartment of the drug dispenser will be an infusion set labeled levetiracetam 15g or placebo Thus for SE patients care providers will administer two agents from the medication dispenser patients will receive either lorazepam 2mg levetiracetam 15 g or lorazepam 3mg placebo Care providers will be instructed by information included with the study drugs to administer the lorazepam over 15-2 minutes this is in line with standard recommendations that lorazepam be administered at a rate not to exceed 2 mgmin28 38 The infusion ie levetiracetam or placebo will be administered over 5 minutes
Inside the non-SE partition in the ED box will be an infusion set labeled levetiracetam 15g or placebo Thus for non-SE patients care providers will administer one agent from the medication dispenser patients will receive either levetiracetam 15 g or placebo Care providers will be instructed by information included with the study drugs to administer the infusion over 5 minutes
The contents of the partitions in the ED drug dispenser will be determined in advance by a randomization scheme that prevents the need for care providers to make a phone call or otherwise spend time which they do not have randomizing patients When the EDs use study drug from either arm of STILL they will contact the Research Pharmacy which will replace the used materials and note the patients medical record number along with the true identity of the study agents administered
Any adjunctive medication may be administered at the discretion of the treating physicians
Study endpoints for SE and non-SE patients are outlined in the Detailed Protocol Briefly SE analysis will focus on whether seizure recurrence is reduced and whether respiratory depression and other post-medication vital signs changes occur less frequently in patients receiving LEV and the smaller dose of lorazepam as compared to those receiving the higher-dose lorazepam alone For non-SE patients endpoints will include seizure recurrence as well as quality of the examination and occurrence of side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None