Status EpilepticusPhase 3RAMPARTNCT00809146
Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
A Phase 3 study testing Intramuscular route of active treatment and Intravenous route of active treatment in people with Status Epilepticus, run by Robert Silbergleit at 17 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Intramuscular route of active treatment and Intravenous route of active treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,023 participants
- Where
- 17 sitesUnited States
- Study dates
- Jun 2009to Jan 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Paramedics or reliable witnesses verify 5 minutes of either continuous seizure activity or of repeated convulsive seizure activity where the patient does not regain consciousness (operationally defined as meaningful speech or obeying commands) between seizures.
- Patient is still seizing at the time of paramedic treatment with study medications.
- Estimated weight equal to or greater than 13 kg.
- Subject to be transported to a RAMPART participating hospital.
Who cannot join
- Major trauma as the precipitant of the seizure
- Hypoglycemia (as defined by local EMS protocol or a glucose < 60 mg/dL)
- Known allergy to midazolam or lorazepam
- Cardiac arrest or heart rate (HR) <40 beats per minute
- Sensitivity to benzodiazepines
- Medical alert tag marked with "RAMPART declined"
Show all 9Show fewer
- Prior treatment of this seizure with diazepam autoinjector as part of another study
- Known pregnancy
- Prisoners
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Emory University
Atlanta, Georgia, 30303
University of Maryland
Baltimore, Maryland, 21201
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Henry Ford Health System
Detroit, Michigan, 48202
Wayne State University
Detroit, Michigan, 48202
University of Texas-Houston
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40536-0298
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55414
New York Presbyterian Hospital
New York, New York, 10032
Stanford University
Palo Alto, California, 94304-5777
University of Pennsylvania/York
Philadelphia, Pennsylvania, 19104
Temple University-Main Line
Philadelphia, Pennsylvania, 19140
Oregon Health and Science University
Portland, Oregon, 97239-3098
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California-San Francisco
San Francisco, California, 94110
University of Arizona
Tucson, Arizona, 85742
About this 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
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.
Read the detailed description
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, the Rapid Anti-convulsant Medication Prior to ARrival Trial (RAMPART), 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 1,024 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).
In September 2010, more rapid than expected enrollment made it feasible to increase the sample size of the study from 800 to 1,024 with the already available funding. The goals of the expansion were to enroll more pediatric subjects (since the trial was enrolling slightly fewer than anticipated) and to improve the power of the study to 90%, which was initially desired. It is important to understand that the extended enrollment was not a sample size re-estimation in any way. The opportunity to extend the trial is pragmatic, based solely on the early enrollment success of the trial. It is not informed by the planned interim analyses that have been performed, the results of which remain sequestered, and there have been no unscheduled interim analyses. The firewall that prevents the blinded leadership from any knowledge of the outcome data has been diligently maintained throughout the process of proposing and implementing this extension.
- Conditions
- Status Epilepticus
- Being tested
- Intramuscular route of active treatment, Intravenous route of active treatment
- Keywords
- Status Epilepticus, Emergency Medical Services, Anticonvulsants, Drug Administration Routes, Seizures
- Medical subject headings
- Status Epilepticus, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscular route of active treatmentDrug
Also called Autoinjector
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 route of active treatmentDrug
Also called Ativan
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.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular (IM) anticonvulsant | Active comparator | This group gets active treatment with an anticonvulsant by the intramuscular route of administration. Receives: Drug: Intramuscular route of active treatment |
| Intravenous (IV) anticonvulsant | Active comparator | This group gets active treatment with an anticonvulsant by the intravenous route of administration. Receives: Drug: Intravenous route of active treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given
The primary outcome was termination of seizures before arrival in the emergency department (ED) without the need for the paramedics to provide rescue therapy. Subjects did not reach the primary outcome if they were having seizures on arrival in the emergency department or if they received rescue medication before arrival. Termination of seizures on arrival was determined according to the clinical judgment of the attending emergency physician and was based on examination of the subjects, their clinical course, and results of any routine diagnostic testing.
Measured: Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).
Secondary outcomes (9)
Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival
Endotracheal intubation performed or attempted by EMS or within 30 minutes after ED arrival is abstracted from the ED record physician and nursing records. Endotracheal intubation includes placement of a definitive tracheal airway (oro-, naso-, cricothyroidotomy, or tracheostomy) for support of respirations or protection of airway. Non-definitive and/or non-tracheal airways (oral or nasal airways, laryngeal mask airways, or esophageal obturator airways) are not included if the patient is not subsequently intubated unless specifically deemed to have been used in lieu of tracheal intubation.
Measured: anytime before 30 minutes after ED arrival
Number of Subjects Hospitalized
Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.
Measured: at ED disposition on day of enrollment
Number of Subjects Admitted to an Intensive Care Unit (ICU)
Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.
Measured: at time of disposition on day of enrollment
Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival
Acute seizure recurrence is defined as any further convulsive or electrographic seizures occurring in the first 12 hours of hospitalization, if they require additional antiepileptic medications, in subjects that had been determined not to be having seizures on ED arrival.
Measured: within 12 hours after ED arrival
Number of Subjects With Hypotension
Acute hypotension is defined as a systolic blood pressure of < 90 mmHg sustained for greater than 5 minutes and for which the patient was treated with a continuous IV infusion of a vasopressor.
Measured: participants were followed for the duration of hospital stay, an average of 6 days
Number of Subjects With IM Injection-site Complications
IM injection site complications are defined as any symptoms or signs of injury or reaction at the site of the study IM injection requiring treatment. This includes extensive hematoma requiring treatment (decompression, pressure dressings, or discontinuation of anticoagulant or antithrombotic medications). Treatment does not include imaging without other interventions. This definition also includes wound infection requiring antibiotic therapy, retained foreign bodies requiring exploration and removal, or other similar wound problems.
Measured: participants were followed for the duration of hospital stay, an average of 6 days
Number of Subjects With IV Injection-site Complications
IV insertion site complications are defined as any symptoms or signs of injury or reaction at the site of the study IV placed by paramedics and used for study medication. This includes thrombosis, phlebitis, or skin infection requiring specific treatment including compresses, antibiotics, or wound care.
Measured: participants were followed for the duration of hospital stay, an average of 6 days
Length of Intensive Care Unit (ICU) Stay in Days
Continuous days of initial ICU stay from time of admission
Measured: participants were followed for the duration of hospital stay, an average of 6 days
Length of Hospital Stay in Days
Continuous acute care inpatient hospital days from day of admission until discharge
Measured: participants were followed for the duration of hospital stay, an average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJun 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Silbergleit
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of South Carolina, University of California, San Francisco, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor-investigator, Robert Silbergleit, University of Michigan
- Investigators
- Robert Silbergleit, MD, Principal investigator, University of MichiganDaniel H Lowenstein, MD, Principal investigator, University of California, San FranciscoValerie L Durkalski, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809146
- Sponsor's protocol ID
- R01NS053031
- Other IDs
- 5U01NS056975-02
- Acronym
- RAMPART
- Status last verified
- May 2016
- First submitted
- 15 Dec 2008
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sherman NA, Silbergleit R, Bengelink EM, Durkalski V, Wolter KD. The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application. Ther Innov Regul Sci. 2023 Jan;57(1):132-141. doi: 10.1007/s43441-022-00447-4. Epub 2022 Aug 20.
PubMed 35987977Silbergleit R, Lowenstein D, Durkalski V, Conwit R; NETT Investigators. Lessons from the RAMPART study--and which is the best route of administration of benzodiazepines in status epilepticus. Epilepsia. 2013 Sep;54 Suppl 6(0 6):74-7. doi: 10.1111/epi.12284.
PubMed 24001080Silbergleit R, Biros MH, Harney D, Dickert N, Baren J; NETT Investigators. Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience. Acad Emerg Med. 2012 Apr;19(4):448-54. doi: 10.1111/j.1553-2712.2012.01328.x.
PubMed 22506949Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012 Feb 16;366(7):591-600. doi: 10.1056/NEJMoa1107494.
PubMed 22335736Silbergleit R, Lowenstein D, Durkalski V, Conwit R; Neurological Emergency Treatment Trials (NETT) Investigators. RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial): a double-blind randomized clinical trial of the efficacy of intramuscular midazolam versus intravenous lorazepam in the prehospital treatment of status epilepticus by paramedics. Epilepsia. 2011 Oct;52 Suppl 8(Suppl 8):45-7. doi: 10.1111/j.1528-1167.2011.03235.x.
PubMed 21967361
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00809146
- Acronym / sponsor ID
- RAMPART / R01NS053031
- Conditions
- Status Epilepticus
- Keywords
- Status Epilepticus, Emergency Medical Services, Anticonvulsants, Drug Administration Routes, Seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- Robert SilbergleitUniversity, hospital or other
- Collaborators
- Medical University of South Carolina, University of California, San Francisco, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 13 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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, the Rapid Anti-convulsant Medication Prior to ARrival Trial (RAMPART), 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 1,024 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).
In September 2010, more rapid than expected enrollment made it feasible to increase the sample size of the study from 800 to 1,024 with the already available funding. The goals of the expansion were to enroll more pediatric subjects (since the trial was enrolling slightly fewer than anticipated) and to improve the power of the study to 90%, which was initially desired. It is important to understand that the extended enrollment was not a sample size re-estimation in any way. The opportunity to extend the trial is pragmatic, based solely on the early enrollment success of the trial. It is not informed by the planned interim analyses that have been performed, the results of which remain sequestered, and there have been no unscheduled interim analyses. The firewall that prevents the blinded leadership from any knowledge of the outcome data has been diligently maintained throughout the process of proposing and implementing this extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular (IM) anticonvulsant | Active comparator | Drug: Intramuscular route of active treatmentThis group gets active treatment with an anticonvulsant by the intramuscular route of administration. |
| Intravenous (IV) anticonvulsant | Active comparator | Drug: Intravenous route of active treatmentThis group gets active treatment with an anticonvulsant by the intravenous route of administration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Paramedics or reliable witnesses verify 5 minutes of either continuous seizure activity or of repeated convulsive seizure activity where the patient does not regain consciousness (operationally defined as meaningful speech or obeying commands) between seizures.
- Patient is still seizing at the time of paramedic treatment with study medications.
- Estimated weight equal to or greater than 13 kg.
- Subject to be transported to a RAMPART participating hospital.
Key exclusion criteria (9 listed)
- Major trauma as the precipitant of the seizure
- Hypoglycemia (as defined by local EMS protocol or a glucose < 60 mg/dL)
- Known allergy to midazolam or lorazepam
- Cardiac arrest or heart rate (HR) <40 beats per minute
- Sensitivity to benzodiazepines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramuscular route of active treatmentAlso: AutoinjectorIM 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. | Drug | Intramuscular (IM) anticonvulsant |
| Intravenous route of active treatmentAlso: AtivanIV 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. | Drug | Intravenous (IV) anticonvulsant |
Primary outcome
Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given
Time frame: Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).
The primary outcome was termination of seizures before arrival in the emergency department (ED) without the need for the paramedics to provide rescue therapy. Subjects did not reach the primary outcome if they were having seizures on arrival in the emergency department or if they received rescue medication before arrival. Termination of seizures on arrival was determined according to the clinical judgment of the attending emergency physician and was based on examination of the subjects, their clinical course, and results of any routine diagnostic testing.
9 secondary outcomes
Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival
Time frame: anytime before 30 minutes after ED arrival
Number of Subjects Hospitalized
Time frame: at ED disposition on day of enrollment
Number of Subjects Admitted to an Intensive Care Unit (ICU)
Time frame: at time of disposition on day of enrollment
Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival
Time frame: within 12 hours after ED arrival
Number of Subjects With Hypotension
Time frame: participants were followed for the duration of hospital stay, an average of 6 days
Number of Subjects With IM Injection-site Complications
Time frame: participants were followed for the duration of hospital stay, an average of 6 days
Number of Subjects With IV Injection-site Complications
Time frame: participants were followed for the duration of hospital stay, an average of 6 days
Length of Intensive Care Unit (ICU) Stay in Days
Time frame: participants were followed for the duration of hospital stay, an average of 6 days
Length of Hospital Stay in Days
Time frame: participants were followed for the duration of hospital stay, an average of 6 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35987977Sherman NA, Silbergleit R, Bengelink EM, Durkalski V, Wolter KD. The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application. Ther Innov Regul Sci. 2023 Jan;57(1):132-141. doi: 10.1007/s43441-022-00447-4. Epub 2022 Aug 20.
- Derived from this study: PubMed 24001080Silbergleit R, Lowenstein D, Durkalski V, Conwit R; NETT Investigators. Lessons from the RAMPART study--and which is the best route of administration of benzodiazepines in status epilepticus. Epilepsia. 2013 Sep;54 Suppl 6(0 6):74-7. doi: 10.1111/epi.12284.
- Derived from this study: PubMed 22506949Silbergleit R, Biros MH, Harney D, Dickert N, Baren J; NETT Investigators. Implementation of the exception from informed consent regulations in a large multicenter emergency clinical trials network: the RAMPART experience. Acad Emerg Med. 2012 Apr;19(4):448-54. doi: 10.1111/j.1553-2712.2012.01328.x.
- Derived from this study: PubMed 22335736Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012 Feb 16;366(7):591-600. doi: 10.1056/NEJMoa1107494.
- Derived from this study: PubMed 21967361Silbergleit R, Lowenstein D, Durkalski V, Conwit R; Neurological Emergency Treatment Trials (NETT) Investigators. RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial): a double-blind randomized clinical trial of the efficacy of intramuscular midazolam versus intravenous lorazepam in the prehospital treatment of status epilepticus by paramedics. Epilepsia. 2011 Oct;52 Suppl 8(Suppl 8):45-7. doi: 10.1111/j.1528-1167.2011.03235.x.
- RAMPART Study Public Information Web SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Silbergleit, MD principal investigator
University of Michigan
Daniel H Lowenstein, MD principal investigator
University of California, San Francisco
Valerie L Durkalski, PhD principal investigator
Medical University of South Carolina
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intramuscular route of active treatment and Intravenous route of active treatment in people with Status Epilepticus, run by Robert Silbergleit at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given (time frame: Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809146, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.