Status EpilepticusPhase 3NCT00116064
Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions
A Phase 3 study testing intranasal lorazepam and intramuscular paraldehyde in people with Status Epilepticus and Convulsions, run by Kamuzu University of Health Sciences at 1 site in Malawi.
Trial summary
The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde. Read more about this study
- Who is it for?
- Ages 2 months to 12 years
- Conditions the study is for
- Status Epilepticus, Convulsions
- What is being tested?
- intranasal lorazepam and intramuscular paraldehyde
- Type of treatment
- Injection or infusion
- How many people
- 156 participants
- Where
- 1 siteMalawi
- Study dates
- Jul 2004to Jun 2005
- 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 2 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 2 months and 12 years
- Presenting with generalised convulsions
Who cannot join
- Any child who had received an anticonvulsant agent within 1 hour of presentation
- Seizure stopped with rapid cooling or treatment of hypoglycaemia
- Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Paediatric Emergency Department, Queen Elizabeth Central Hospital
Blantyre
About this study
Official title: A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children
The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.
Read the detailed description
The ideal first line anticonvulsant agent would be one that can be safely and easily given at a primary health care facility. It should be quick acting, have minimal cardiorespiratory side effects and have a relatively prolonged effect and be cheap. No combination of drug or delivery system fully satisfies these criteria. There are no large published studies evaluating intranasal lorazepam in paediatric status epilepticus. Given its favourable pharmacokinetics and potential practical advantages, we wished to assess the efficacy and safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our existing first line anticonvulsant agent in the treatment of acute seizures in children.
- Conditions
- Status Epilepticus, Convulsions
- Being tested
- intranasal lorazepam, intramuscular paraldehyde
- Keywords
- intranasal, lorazepam, paediatric, convulsions
- 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.
intranasal lorazepamDrug
intramuscular paraldehydeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
Secondary outcomes (5)
time from drug administration to cessation of convulsion
frequency of episodes requiring 2 or more anticonvulsant agents
continuous blood pressure and oxygen saturation for 30 minutes post drug administration
seizure recurrence within 24 hours of cessation of presenting convulsion
survival/death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study startJul 2004
- Study completionJun 2005
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
- 156 participants
Sponsor and investigators
- Lead sponsor
- Kamuzu University of Health Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Elizabeth Molyneux, MRCPCH FFAEM, Study director, Kamuzu University of Health SciencesShafique Ahmad, MRCPCH FFAEM, Principal investigator, Kamuzu University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116064
- Sponsor's protocol ID
- P03/04/248
- Status last verified
- Jun 2005
- First submitted
- 26 Jun 2005
- Last updated
- 21 Jul 2006
- Results posted
- No
Publications
Ahmad S, Ellis JC, Kamwendo H, Molyneux E. Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open randomised trial. Lancet. 2006 May 13;367(9522):1591-7. doi: 10.1016/S0140-6736(06)68696-0.
PubMed 16698412
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children
- ClinicalTrials.gov ID
- NCT00116064
- Acronym / sponsor ID
- P03/04/248
- Conditions
- Status Epilepticus, Convulsions
- Keywords
- intranasal, lorazepam, paediatric, convulsions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants
- Lead sponsor
- Kamuzu University of Health SciencesUniversity, hospital or other
- Study start
- Jul 2004
- Study completion
- Jun 2005
- First posted
- 27 Jun 2005 (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 purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.
Detailed description
The ideal first line anticonvulsant agent would be one that can be safely and easily given at a primary health care facility. It should be quick acting, have minimal cardiorespiratory side effects and have a relatively prolonged effect and be cheap. No combination of drug or delivery system fully satisfies these criteria. There are no large published studies evaluating intranasal lorazepam in paediatric status epilepticus. Given its favourable pharmacokinetics and potential practical advantages, we wished to assess the efficacy and safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our existing first line anticonvulsant agent in the treatment of acute seizures in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged between 2 months and 12 years
- Presenting with generalised convulsions
Key exclusion criteria (3 listed)
- Any child who had received an anticonvulsant agent within 1 hour of presentation
- Seizure stopped with rapid cooling or treatment of hypoglycaemia
- Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy
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 |
|---|---|---|
| intranasal lorazepam | Drug | – |
| intramuscular paraldehyde | Drug | – |
Primary outcome
whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
5 secondary outcomes
time from drug administration to cessation of convulsion
frequency of episodes requiring 2 or more anticonvulsant agents
continuous blood pressure and oxygen saturation for 30 minutes post drug administration
seizure recurrence within 24 hours of cessation of presenting convulsion
survival/death
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 21 Jul 2006.
- Results publication: PubMed 16698412Ahmad S, Ellis JC, Kamwendo H, Molyneux E. Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open randomised trial. Lancet. 2006 May 13;367(9522):1591-7. doi: 10.1016/S0140-6736(06)68696-0.
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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.
Elizabeth Molyneux, MRCPCH FFAEM study director
Kamuzu University of Health Sciences
Shafique Ahmad, MRCPCH FFAEM principal investigator
Kamuzu University of Health Sciences
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 intranasal lorazepam and intramuscular paraldehyde in people with Status Epilepticus and Convulsions, run by Kamuzu University of Health Sciences at 1 site in Malawi.
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 3 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 21 Jul 2006. 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 Malawi. 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?
whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration. 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 NCT00116064, 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 21 Jul 2006.