Status EpilepticusPhase 1NCT04679623
Study of Midazolam in Healthy Adults
A Phase 1 study testing Midazolam and Seizalam in people with Status Epilepticus, run by Rafa Laboratories at 1 site in United States.
Trial summary
This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared with seizalam in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Midazolam and Seizalam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 17 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Can understand and provide signed informed consent
- Is a healthy male or healthy, non-pregnant, non-lactating female whose screening, physical exam, labs, vitals, and ECG are within normal range
- Has a willingness to comply and be available for all protocol procedures
- Is between age 18 and 55 years, inclusive on the day of injection
- If the subject is female and of childbearing potential, she has a negative serum pregnancy test at screening and negative urine test within 24 hours prior to injection Note: A woman is considered of childbearing potential unless post-menopausal (≥ 1 year without menses) or surgically sterilized via bilateral oophorectomy, or hysterectomy or bilateral tubal ligation or successful Essure placement with documented confirmation test at least 3 months after the procedure
- If the subject is female and of childbearing potential, she agrees to practice abstinence from sexual intercourse with men or use acceptable contraception up to 1 month after the end of study visit Note: Acceptable contraception methods are restricted to effective devices (approved oral contraceptives, Intrauterine Contraceptive Devices, NuvaRing®)
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- If the subject is male, he agrees to practice abstinence from sexual intercourse with women or use acceptable contraception up to 1 month after the end of study visit
- Has a body mass index (BMI) ≥18.0 and ≤26.0 kg/m2 at screening
- Has a negative urine drug screen
- Has a negative breathalyzer test
- Subject is not taking any medications or St. John's wort and agrees to avoid grapefruit juice and alcohol until study completion on Day 28
- Subject agrees to not take any vitamins or supplements 48 hours prior to dosing
- Is available for follow-up for the duration of the study
Who cannot join
- Received treatment with another investigational drug within 28 days of initial dosing
- Has a current or history of drug and /or alcohol abuse
- Is pregnant or breastfeeding woman
- Has hypersensitivity or allergy to midazolam
- Has hypersensitivity or allergy to benzodiazepines
- Has a history of cardiovascular, pulmonary, neurological, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or psychiatric disease or any other reason, in the opinion of the investigator, that the patient should not participate
- Tests positive for HIV-1, HIV-2, HbsAg, hepatitis C antibody, or syphilis
- Has had a blood donation in the 8 weeks prior to the study period start date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Comparison Study to Evaluate the Safety and Pharmacokinetics of a Single Intramuscular Administration of 10 mg Midazolam Using an Auto-Injector vs Marketed Midazolam Vials in Healthy Adults.
This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared with seizalam in healthy adults. All subjects will participate in both study periods which will span 28 days following a pre study screening visit.
- Conditions
- Status Epilepticus
- Being tested
- Midazolam, Seizalam
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamCombination product
Midazolam Injection, 10mg
SeizalamDrug
Seizalam, 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Midazolam Injection | Experimental | Midazolam injection, 10 mg Receives: Combination Product: Midazolam |
| Seizalam™ | Active comparator | Seizalam, 10 mg Receives: Drug: Seizalam |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with local injection site changes
Measured: 28 days
number of participants with systemic changes in physical exam
Measured: 28 days
number of participants with vital signs changes resulting in a serious adverse event
Measured: 28 days
number of participants with ECG changes resulting in a serious adverse event
Measured: 28 days
number of participants with laboratory changes resulting in a serious adverse event
Measured: 28 days
time to reach Cmax (Tmax) will be obtained directly from the plasma concentration-time profile data for each patient following IM injection
Measured: 28 days
The elimination rate constant (ke) will be estimated
Measured: 28 days
The AUC from time 0 to the time of the last measurable concentration (AUC0-last) and the AUC from time zero to infinite time (AUC0-∞)
Measured: 28 days
Secondary outcomes (3)
Relative bioavailability will be obtained by analysis of Cmax
Measured: 28 days
Relative bioavailability will be obtained by analysis of AUC0-last
Measured: 28 days
Relative bioavailability will be obtained by analysis of AUC0-∞
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start9 Jun 2021
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rafa Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alachua Government Services, Inc., Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679623
- Sponsor's protocol ID
- RLM-559-01
- Status last verified
- Mar 2022
- First submitted
- 15 Dec 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Comparison Study to Evaluate the Safety and Pharmacokinetics of a Single Intramuscular Administration of 10 mg Midazolam Using an Auto-Injector vs Marketed Midazolam Vials in Healthy Adults.
- ClinicalTrials.gov ID
- NCT04679623
- Acronym / sponsor ID
- RLM-559-01
- Conditions
- Status Epilepticus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rafa LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Alachua Government Services, Inc., Joint Project Management Office for Chemical, Biological, Radiological, and Nuclear Medical
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's auto-injector compared with seizalam in healthy adults. All subjects will participate in both study periods which will span 28 days following a pre study screening visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam Injection | Experimental | Combination Product: MidazolamMidazolam injection, 10 mg |
| Seizalam™ | Active comparator | Drug: SeizalamSeizalam, 10 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Can understand and provide signed informed consent
- Is a healthy male or healthy, non-pregnant, non-lactating female whose screening, physical exam, labs, vitals, and ECG are within normal range
- Has a willingness to comply and be available for all protocol procedures
- Is between age 18 and 55 years, inclusive on the day of injection
- If the subject is female and of childbearing potential, she has a negative serum pregnancy test at screening and negative urine test within 24 hours prior to injection Note: A woman is considered of childbearing potential unless post-menopausal (≥ 1 year without menses) or surgically sterilized via bilateral oophorectomy, or hysterectomy or bilateral tubal ligation or successful Essure placement with documented confirmation test at least 3 months after the procedure
Key exclusion criteria (8 listed)
- Received treatment with another investigational drug within 28 days of initial dosing
- Has a current or history of drug and /or alcohol abuse
- Is pregnant or breastfeeding woman
- Has hypersensitivity or allergy to midazolam
- Has hypersensitivity or allergy 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 |
|---|---|---|
| MidazolamMidazolam Injection, 10mg | Combination product | Midazolam Injection |
| SeizalamSeizalam, 10 mg | Drug | Seizalam™ |
Primary outcome
number of participants with local injection site changes
Time frame: 28 days
number of participants with systemic changes in physical exam
Time frame: 28 days
number of participants with vital signs changes resulting in a serious adverse event
Time frame: 28 days
number of participants with ECG changes resulting in a serious adverse event
Time frame: 28 days
number of participants with laboratory changes resulting in a serious adverse event
Time frame: 28 days
time to reach Cmax (Tmax) will be obtained directly from the plasma concentration-time profile data for each patient following IM injection
Time frame: 28 days
The elimination rate constant (ke) will be estimated
Time frame: 28 days
The AUC from time 0 to the time of the last measurable concentration (AUC0-last) and the AUC from time zero to infinite time (AUC0-∞)
Time frame: 28 days
3 secondary outcomes
Relative bioavailability will be obtained by analysis of Cmax
Time frame: 28 days
Relative bioavailability will be obtained by analysis of AUC0-last
Time frame: 28 days
Relative bioavailability will be obtained by analysis of AUC0-∞
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam and Seizalam in people with Status Epilepticus, run by Rafa Laboratories at 1 site 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 13 inclusion and 8 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 participants with local injection site changes (time frame: 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.