SeizuresPhase 4NCT02897856
Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures
A Phase 4 study testing Buccal midazolam and Intramuscular midazolam in people with Seizures, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Seizures
- What is being tested?
- Buccal midazolam and Intramuscular midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteQatar
- Study dates
- Sep 2016to Nov 2018
- Phase
- Phase 4
- 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 6 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6 month to 14 years who will be presented to the pediatric emergency or attended by emergency medical service who have active seizure and had no intravenous access would be eligible for the study.
Who cannot join
- Cardiac arrest
- Head trauma
- Drowning
- Congenital heart disease
- Inborn errors of metabolism
- Electrolyte imbalance (hypocalcaemia, hyponatremia and hypoglycemia)
Show all 9Show fewer
- Hemodynamic instability
- Allergy to benzodiazepines
- Focal seizures with preserved level of consciousness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial
The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.
Read the detailed description
Both buccal and intramuscular midazolam have been used to control seizures with variable succuss rates and side effects.
In this study the investigators are going to assign patient randomly to receive either buccal or intramuscular midazolam. Then will compare both efficacy and side effect in both groups.
- Conditions
- Seizures
- Being tested
- Buccal midazolam, Intramuscular midazolam
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal midazolamDrug
Study subject will receive Buccal midazolam, Intramuscular placebo.
Intramuscular midazolamDrug
Study subject will receive Intramuscular midazolam,Buccal placebo
| Study group | Role | What they receive |
|---|---|---|
| Buccal midazolam | Active comparator | Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg Receives: Drug: Buccal midazolam |
| intramuscular midazolam | Active comparator | Study subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg. Receives: Drug: Intramuscular midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of seizure activity five minutes after treatment with study medication.
Cessation of abnormal motor activity with regaining of consciousness.
Measured: five minutes
Secondary outcomes (3)
Major side effects.
Measured: 2 hours after cessation of seizures.
Duration of seizure.
Measured: 5 minutes
Recurrence of seizure activity within one hour after treatment with study medication.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, DR. KHALID AL-ANSARI, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897856
- Sponsor's protocol ID
- 14-00050
- Status last verified
- Jul 2019
- First submitted
- 4 Sep 2016
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02897856
- Acronym / sponsor ID
- 14-00050
- Conditions
- Seizures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.
Detailed description
Both buccal and intramuscular midazolam have been used to control seizures with variable succuss rates and side effects.
In this study the investigators are going to assign patient randomly to receive either buccal or intramuscular midazolam. Then will compare both efficacy and side effect in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buccal midazolam | Active comparator | Drug: Buccal midazolamStudy subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg |
| intramuscular midazolam | Active comparator | Drug: Intramuscular midazolamStudy subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 6 month to 14 years who will be presented to the pediatric emergency or attended by emergency medical service who have active seizure and had no intravenous access would be eligible for the study.
Key exclusion criteria (9 listed)
- Cardiac arrest
- Head trauma
- Drowning
- Congenital heart disease
- Inborn errors of metabolism
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 |
|---|---|---|
| Buccal midazolamStudy subject will receive Buccal midazolam, Intramuscular placebo. | Drug | Buccal midazolam |
| Intramuscular midazolamStudy subject will receive Intramuscular midazolam,Buccal placebo | Drug | intramuscular midazolam |
Primary outcome
Cessation of seizure activity five minutes after treatment with study medication.
Time frame: five minutes
Cessation of abnormal motor activity with regaining of consciousness.
3 secondary outcomes
Major side effects.
Time frame: 2 hours after cessation of seizures.
Duration of seizure.
Time frame: 5 minutes
Recurrence of seizure activity within one hour after treatment with study medication.
Time frame: one hour
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 24 Jul 2019.
- Individual participant dataSharing planned: No
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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 4 study testing Buccal midazolam and Intramuscular midazolam in people with Seizures, run by Hamad Medical Corporation at 1 site in Qatar.
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 1 inclusion and 9 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 24 Jul 2019. 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 Qatar. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Cessation of seizure activity five minutes after treatment with study medication. (time frame: five minutes). 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 24 Jul 2019.