CompletedPhase 1

Phase I Trail for Intramuscular Administration of Midazolam Using An Autoinjector

United States39 participantsStarted 2006-07

Plain-language summary

Purpose of the study is to determine midazolam's safety and dose-linearity when delivered intramuscularly via an autoinjector. The proposed initial treatment dosage for seizures induced by exposure to nerve agents.

Who can participate

Age range

18 Years – 54 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Generally health adult * Physically fit * Body Mass Index of \>/- 19 and \</- 26 and a body weight of 55 to 85 Kg * Have adequate venous access and sufficient upper leg muscle tissue * Have all specified laboratory values * Have a negative assay for HIV-1, HIV-2, HbsAg * If femal is of child bearing potential, she must not be pregnant or breast feeding, nor plan to become pregnant for th eduration of the study. She must have a negative blood serum pregnancy test within 21 days of treatment, and a negative urine pregnancy test prior to dosing. * Females of childbearing potential will use adequate contraception. * Willing to refrain from donating blood for 8 weeks after compeletion of the study. Exclusion Criteria: * Participated in a pharmacokinetic study or any clinical study currently or within the last 30 days or donated \>480mL of blood within the last 8 weeks. * History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestingal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease that could potentially impact the safety of the subject or metabolism of the drug. * Be taking any medications to ttreat a chronic medical condition * Have ongoing drug abuse/dependence (including alcohol); or history of or treatment for alcohol or drug abuse * History of allergic or untoward reaction to any benzodiazepine or any psychotropic agent * Currently suffering frm acute or chronic pulmonary disease * Clinically…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00534378

SponsorU.S. Army Office of the Surgeon General

Sponsor typeFED

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Seizures trials

Who can participate

Age range

18 Years – 54 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.