Status EpilepticusPhase 3INLORNCT00735527
Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
A Phase 3 study testing Lorazepam in people with Status Epilepticus and Seizures, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Status Epilepticus, Seizures
- What is being tested?
- Lorazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- May 2008to Apr 2009
- Phase
- Phase 3
- 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 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children presenting convulsing to the pediatric emergency or developing seizure while in casualty
- Age 6-14 years
Who cannot join
- Known hypersensitivity to any benzodiazepine
- Child has received any parenteral anti-convulsant within 1 hr prior to enrollment
- Presence of severe cardio-respiratory compromise or cardiac arrhythmias
- Presence of upper respiratory tract infection
- Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial
Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.
- Conditions
- Status Epilepticus, Seizures
- Being tested
- Lorazepam
- Keywords
- seizures, status epilepticus, lorazepam, intra-nasal
- Medical subject headings
- Status Epilepticus, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
Intra-nasal 0.1 mg/kg (maximum 4 mg) once
LorazepamDrug
Intra-venous 0.1 mg/kg (maximum 4 mg) once
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intra-nasal lorazepam 0.1 mg/kg (max 4 mg) Receives: Drug: Lorazepam |
| 2 | Active comparator | Intra-venous lorazepam 0.1 mg/kg (max 4 mg) Receives: Drug: Lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of all clinical seizure activity within 10 min of drug administration
Measured: 10 min
Secondary outcomes (6)
Persistent cessation of seizure activity for 1 hr
Measured: 1 hr
Patients requiring rescue medication within 1 hr
Measured: 1 hr
Time to achieve intra-venous access after arrival in casualty
Measured: minutes
Time from drug administration to termination of seizure(s)
Measured: minutes
Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration
Measured: 1 hr
Development of significant respiratory depression requiring assisted ventilation
Measured: 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735527
- Sponsor's protocol ID
- INLOR
- Acronym
- INLOR
- Status last verified
- May 2009
- First submitted
- 12 Aug 2008
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Intranasal versus intravenous lorazepam for control of acute seizures in children: a randomized open-label study. Epilepsia. 2011 Apr;52(4):788-93. doi: 10.1111/j.1528-1167.2010.02949.x. Epub 2011 Jan 28.
PubMed 21275979
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial
- ClinicalTrials.gov ID
- NCT00735527
- Acronym / sponsor ID
- INLOR / INLOR
- Conditions
- Status Epilepticus, Seizures
- Keywords
- seizures, status epilepticus, lorazepam, intra-nasal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Aug 2008 (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.
Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LorazepamIntra-nasal lorazepam 0.1 mg/kg (max 4 mg) |
| 2 | Active comparator | Drug: LorazepamIntra-venous lorazepam 0.1 mg/kg (max 4 mg) |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children presenting convulsing to the pediatric emergency or developing seizure while in casualty
- Age 6-14 years
Key exclusion criteria (5 listed)
- Known hypersensitivity to any benzodiazepine
- Child has received any parenteral anti-convulsant within 1 hr prior to enrollment
- Presence of severe cardio-respiratory compromise or cardiac arrhythmias
- Presence of upper respiratory tract infection
- Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea
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 |
|---|---|---|
| LorazepamIntra-nasal 0.1 mg/kg (maximum 4 mg) once | Drug | 1 |
| LorazepamIntra-venous 0.1 mg/kg (maximum 4 mg) once | Drug | 2 |
Primary outcome
Cessation of all clinical seizure activity within 10 min of drug administration
Time frame: 10 min
6 secondary outcomes
Persistent cessation of seizure activity for 1 hr
Time frame: 1 hr
Patients requiring rescue medication within 1 hr
Time frame: 1 hr
Time to achieve intra-venous access after arrival in casualty
Time frame: minutes
Time from drug administration to termination of seizure(s)
Time frame: minutes
Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration
Time frame: 1 hr
Development of significant respiratory depression requiring assisted ventilation
Time frame: 1 hr
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 5 May 2009.
- Derived from this study: PubMed 21275979Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Intranasal versus intravenous lorazepam for control of acute seizures in children: a randomized open-label study. Epilepsia. 2011 Apr;52(4):788-93. doi: 10.1111/j.1528-1167.2010.02949.x. Epub 2011 Jan 28.
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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 3 study testing Lorazepam in people with Status Epilepticus and Seizures, run by All India Institute of Medical Sciences at 1 site in India.
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 2 inclusion and 5 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 5 May 2009. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 all clinical seizure activity within 10 min of drug administration (time frame: 10 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735527, which also lists 1 linked publication.
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 5 May 2009.