drugset / Trial / NCT00809146
Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
Phase 3
Completed
1023 enrolled
Robert Silbergleit
Medical University of South Carolina · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabUniversity of California, San Francisco · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2009-06
- Primary completion
- 2011-01
- Completion
- 2011-01
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.
- Silbergleit 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.
- Silbergleit 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.
- Silbergleit 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.
- Silbergleit 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Intramuscular route of active treatment | Unknown | 4 mg | Intramuscular |
| Comparator | Intramuscular route of active treatment | Unknown | 5 mg | Intramuscular |
| Comparator | Intramuscular route of active treatment | Unknown | 10 mg | Intramuscular |
| Comparator | Lorazepam | Small molecule | 2 mg | Intravenous |
Indications
No indication recorded.