Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

Intranasal Midazolam Versus Rectal Diazepam for Treatment of Seizures

NCT00326612 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG Midazolam
  • DRUG Diazepam

Study Locations (1)

Utah

  • Primary Children's Medical Center — Salt Lake City

Trial Details

FieldValue
Enrollment Target 358 participants
Start Date 2006-06
Est. Completion 2008-12
Phase Phase 2

Sponsor

University of Utah

686 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00326612

The ClinicalTrials.gov registry entry for NCT00326612 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 358 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 686 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00326612 reports 1 study location spanning 1 distinct geographic area — top geographies include Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00326612?

The interventions under investigation include: Midazolam (DRUG), Diazepam (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00326612?

This trial is sponsored by University of Utah, which has 686 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial