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NCT00326612 · ClinicalTrials.gov registry record · Phase 2
Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures
A Phase 2 study of Seizures, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 358
- Enrollment target
- 1
- Study location
NCT00326612: Completed Phase 2 study of Seizures, sponsored by University of Utah.
NCT00326612 is a Phase 2 study of Seizures that has completed, run by University of Utah. The registered enrollment target is 358 participants, below the 925-participant average among 39 other Seizures trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00326612, a Phase 2 study of Seizures, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 358 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will conduct a randomized controlled trial comparing the use of nasal midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute seizure activity in children under the age of 18 years with epilepsy in the community setting. The primary hypothesis is that nasal midazolam will be more effective and have shorter seizure time compared to rectal diazepam in the community. The secondary hypotheses are that patients treated with nasal midazolam will have fewer respiratory complications, emergency department visits, and admissions.
Primary Outcome
Length of seizure.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Diazepam
Study Locations (1)
Utah
- Primary Children's Medical Center - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2006-06 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00326612 record still lists
NCT00326612 is an interventional study that assigns participants to a tested intervention. The registered 358 participants enrollment target is mid-sized for trials with a published cap, below the 925-participant average among 39 other Seizures trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Seizures appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.
NCT00326612 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT00326612 about?
NCT00326612 is a clinical study titled "Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures". The investigators will conduct a randomized controlled trial comparing the use of nasal midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute seizure activity in children under the age of 18 years with epilepsy in the community setting. The primary hypothesis i...
What is the current status of trial NCT00326612?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 358 participants. The study started on 2006-06. Estimated completion is 2008-12.
What conditions does trial NCT00326612 study?
This clinical trial studies the following conditions: Seizures.
What interventions are being tested in trial NCT00326612?
The interventions under investigation include: Midazolam (DRUG), Diazepam (DRUG).
Who is sponsoring clinical trial NCT00326612?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00326612 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Seizures
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00326612's enrollment target sits among peer trials
358 10th of 39 higher than 30 of 39 other Seizures trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Seizures trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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