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| Sponsor: | University of Michigan |
|---|---|
| Collaborators: |
Medical University of South Carolina University of California, San Francisco National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00809146 |
Purpose
The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.
| Condition | Intervention | Phase |
|---|---|---|
|
Status Epilepticus |
Other: Intramuscular route of active treatment Other: Intravenous route of active treatment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-blind Randomized Clinical Trial of the Efficacy of IM Midazolam Versus IV Lorazepam in the Pre-hospital Treatment of Status Epilepticus by Paramedics |
| Estimated Enrollment: | 800 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Intramuscular (IM) anticonvulsant: Active Comparator
This group gets active treatment with an anticonvulsant by the intramuscular route of administration.
|
Other: Intramuscular route of active treatment
IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
|
|
Intravenous (IV) anticonvulsant: Active Comparator
This group gets active treatment with an anticonvulsant by the intravenous route of administration.
|
Other: Intravenous route of active treatment
IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
|
Seizures are a common medical problem. Although they can be frightening to watch, most seizures are brief and stop by themselves. Seizures that don't stop in seconds or minutes are a dangerous life-threatening medical emergency. Paramedics often have medications that can stop seizures, but the best way to give the medicines is not known. Paramedics often give medicine directly into a vein, which is called intravenous (IV) administration. This works well, but can be hard to do in a person who is seizing. It can also take some time and delay treatment. Another way to give the medicine is as a shot given into a muscle, which is called intramuscular (IM) administration. Giving the medicine this way is faster, but it may not stop the seizure as quickly.
This clinical trial is designed to figure out whether giving anti-seizure medicine works similarly well and more quickly when given through an IV or when given as a shot in the muscle. Two similar medicines will be used. Both are already used by paramedics in the field and by doctors in the hospital to stop seizures. One is commonly given by IV, and the other is commonly given as a shot in the muscle. In this study, the shot will be given using a device similar to an EpiPen—which is an autoinjector used by people with severe allergies.
Approximately 800 persons whose seizures are continuing after emergency medical service (EMS) arrival and who meet all eligibility criteria will be enrolled in the trial. Every participant will be treated with anti-seizure medicine by the paramedics. At random, half the participants will be in one group and half in another. Half the participants will receive the study medicine through an IV and will be given a shot in the muscle without medicine (placebo). The other half will receive the medicine as a shot in the muscle plus an IV without medicine (placebo).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Robert Silbergleit, MD | 724-232-2142 | robie@umich.edu |
| United States, Arizona | |
| University of Arizona | Recruiting |
| Tucson, Arizona, United States, 85742 | |
| Contact: Kurt Denninghoff, MD 520-626-1551 kdenninghoff@aemrc.arizona.edu | |
| Contact: Bruce Barnhart BBarnhart@aemrc.arizona.edu | |
| Principal Investigator: Kurt Denninghoff, MD | |
| Sub-Investigator: Daniel Spaite, MD | |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304-5777 | |
| Contact: James Quinn, MD 650-736-4391 jquinn@stanfordmed.org | |
| Contact: Stephanie Casal scasal@stanford.edu | |
| Principal Investigator: James V Quinn, MD | |
| University of California-San Francisco | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Claude Hemphill, MD 415-206-3213 chemphill@sfgh.ucsf.edu | |
| Contact: Michele Meeker, RN meekerm@neurosurg.ucsf.edu | |
| Principal Investigator: Claude Hemphill, MD | |
| Sub-Investigator: Karl Sporer, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: David Wright, MD 404-778-1709 David.Wright@Emory.edu | |
| Contact: Harriet Howlett-Smith, RN hhowlet@emory.edu | |
| Principal Investigator: David Wright, MD | |
| Sub-Investigator: Bittner Matthew, MD | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0298 | |
| Contact: Roger Humphries, MD 859-323-5908 rlhump0@uky.edu | |
| Contact: Christofer Sweat sweatclfd@gmail.com | |
| Principal Investigator: Roger Humphries, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Robert Welch, MD 313-993-2534 rwelch@med.wayne.edu | |
| Contact: LynnMarie Mango lmmango@med.wayne.edu | |
| Principal Investigator: Robert Welch, MD | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Christopher Lewandowski, MD 313-916-1553 clewand1@hfhs.org | |
| Contact: Paula Crouse PCROUSE1@hfhs.org | |
| Principal Investigator: Christopher Lewandowski, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55414 | |
| Contact: Michelle Biros, MD 612-873-7586 michelle.biros@gmail.com | |
| Contact: Corey Sargent sarge022@umn.edu | |
| Principal Investigator: Michelle H Biros, MD | |
| United States, Ohio | |
| University of Cincinnati Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Arthur Pancioli, MD 513-558-8103 pancioam@ucmail.uc.edu | |
| Contact: Irene Ewing, RN irene.ewing@uc.edu | |
| Principal Investigator: Arthur Pancioli, MD | |
| Sub-Investigator: Jason McMullan, MD | |
| United States, Oregon | |
| Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Robert Lowe, MD 503-494-7551 lowero@ohsu.edu | |
| Contact: Rachel Stone stonera@ohsu.edu | |
| Principal Investigator: Robert Lowe, MD | |
| Sub-Investigator: Craig Warden, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania/York | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Jill Baren, MD 215-662-6917 barenj@uphs.upenn.edu | |
| Contact: Katie Lamond Katherine.Lamond@uphs.upenn.edu | |
| Principal Investigator: Jill Baren, MD | |
| Sub-Investigator: R. Daniel Bledsoe, MD | |
| Temple University | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Nina Gentile, MD ngentile@temple.edu | |
| Contact: Christopher Vates cvates@temple.edu | |
| Principal Investigator: Nina Gentile, MD | |
| United States, Texas | |
| University of Texas-Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Elizabeth Jones, MD 713-500-7864 Elizabeth.B.Jones@uth.tmc.edu | |
| Contact: Misty Ottman misty.ottman@uth.tmc.edu | |
| Principal Investigator: Elizabeth Jones, MD | |
| Sub-Investigator: Bonnie Richter, MD | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Joseph Ornato, MD 804-828-7184 jpornato@vcu.edu | |
| Contact: Michael Kurz mkurz@mcvh-vcu.edu | |
| Principal Investigator: Joseph P Ornato, MD | |
| Sub-Investigator: Michael Kurz, MD | |
| Principal Investigator: | Robert Silbergleit, MD | University of Michigan |
| Principal Investigator: | Daniel H Lowenstein, MD | University of California, San Francisco |
| Principal Investigator: | Valerie L Durkalski, PhD | Medical University of South Carolina |
More Information
| Responsible Party: | University of Michigan ( Robert Silbergleit, MD, Principal Investigator ) |
| Study ID Numbers: | R01NS053031, 5U01NS056975-02 |
| Study First Received: | December 15, 2008 |
| Last Updated: | January 27, 2010 |
| ClinicalTrials.gov Identifier: | NCT00809146 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Status Epilepticus Emergency Medical Services Anticonvulsants Drug Administration Routes Seizures |
|
Epilepsy Therapeutic Uses Status Epilepticus Nervous System Diseases Central Nervous System Diseases |
Brain Diseases Central Nervous System Agents Pharmacologic Actions Anticonvulsants |