NCT00116064 is a Phase 3 clinical trial of intranasal lorazepam in Status Epilepticus, sponsored by Kamuzu University of Health Sciences.

Who is sponsoring NCT00116064?

NCT00116064 is sponsored by Kamuzu University of Health Sciences.

What drugs are being tested in NCT00116064?

Interventions in NCT00116064: intranasal lorazepam, intramuscular paraldehyde.

What condition does NCT00116064 study?

NCT00116064 studies Status Epilepticus, Convulsions.

Is NCT00116064 still recruiting?

NCT00116064 is currently completed. Last updated 20 July 2006.

Last reviewed 2006-07-20 · How we verify

NCT00116064

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children

Completed Phase 3 Last updated 20 July 2006

What this trial tests

Phase 3 trial testing intranasal lorazepam in Status Epilepticus in 156 participants. Completed in 1 June 2005.

Timeline

1 July 2004

1 June 2005

Quick facts

Lead sponsor	Kamuzu University of Health Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	156
Start date	1 July 2004
Estimated completion	1 June 2005
Sites	1 location across Malawi

Drugs / interventions tested

intranasal lorazepam — full drug profile →
intramuscular paraldehyde — full drug profile →

Conditions studied

Status Epilepticus — all drugs for Status Epilepticus →
Convulsions — all drugs for Convulsions →

Sponsor

Kamuzu University of Health Sciences

Who can join

Adults 2 Months to 12, any sex, with Status Epilepticus or Convulsions. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open randomised trial.
Ahmad S, Ellis JC, Kamwendo H, Molyneux E. · · 2006 · cited 65× · PMID 16698412 · DOI 10.1016/s0140-6736(06)68696-0

Verify or expand the search:

Other recruiting trials for Status Epilepticus

Currently open trials in the same condition.

NCT06401707 — PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest · Phase 2 · recruiting
NCT06194747 — Improving Status Epilepticus Treatment Times · NA · recruiting
NCT06017973 — The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus · NA · recruiting
NCT05851391 — buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest · Phase 2 · recruiting
NCT05839418 — Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status · recruiting

Other Kamuzu University of Health Sciences trials

Trials by the same sponsor.

NCT06617130 — The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnu · NA · not yet recruiting
NCT06424002 — The Impact RTS,S/AS01 Vaccine in School Aged Children RTS,S/AS01 Malaria Vaccine in School Aged Children · Phase 4 · not yet recruiting
NCT06900361 — Use of Mobile Phone Application for Asthma Sele Management · completed
NCT04625452 — Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants · NA · unknown
NCT03376217 — Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00116064 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kamuzu University of Health Sciences
Last refreshed: 20 July 2006

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00116064.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing