NCT02897856

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

2.2 years

First QC Date

September 4, 2016

Last Update Submit

July 23, 2019

Conditions

Seizures

Outcome Measures

Primary Outcomes (1)

  • Cessation of seizure activity five minutes after treatment with study medication.

    Cessation of abnormal motor activity with regaining of consciousness.

    five minutes

Secondary Outcomes (3)

  • Major side effects.

    2 hours after cessation of seizures.

  • Duration of seizure.

    5 minutes

  • Recurrence of seizure activity within one hour after treatment with study medication.

    one hour

Study Arms (2)

Buccal midazolam

ACTIVE COMPARATOR

Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg

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.

Drug: Intramuscular midazolam

Interventions

Buccal midazolamDRUG

Study subject will receive Buccal midazolam, Intramuscular placebo.

Buccal midazolam
Intramuscular midazolamDRUG

Study subject will receive Intramuscular midazolam,Buccal placebo

intramuscular midazolam

Eligibility Criteria

Age6 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Cardiac arrest
  • Head trauma
  • Drowning
  • Congenital heart disease
  • Inborn errors of metabolism
  • Electrolyte imbalance (hypocalcaemia, hyponatremia and hypoglycemia)
  • Hemodynamic instability
  • Allergy to benzodiazepines
  • Focal seizures with preserved level of consciousness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad medical corporation

Doha, 3050, Qatar

Location

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultanat

Study Record Dates

First Submitted

September 4, 2016

First Posted

September 13, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

QA(1)