NCT01434225

NEMO1:NEonatal Seizure Using Medication Off-patent

NEMO1: An Open Label Exploratory Dose Finding and Pharmacokinetic Clinical Trial of Bumetanide for the Treatment of Neonatal Seizure Using Medication Off-patent

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 48 Hours
• Healthy volunteers: Not accepted

Summary

NEMO is a multicentre pan European clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. There is evidence that bumetanide improves GABAergic function of the current standard drug, phenobarbitone. Bumetanide has been used as a diuretic in term and preterm babies for around thirty years. This trial should confirm that Bumetanide in addition to standard treatment will result in better seizures control.

Conditions

• Neonatal Seizures

Interventions

Type	Name	Description
DRUG	Bumetanide	Bumetanide - Standard Phenobarbital plus either 0.05 mg/kg,0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg of bumetanide as determined by the the dose escalation design Maximum dose allowed is 0.3mg/kg given up to 4 times at 12 hourly intervals (total of 1.2mg/kg).

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-09-14
• Last updated: 2015-09-14

Locations

7 sites across 4 countries: Ireland, Netherlands, Sweden, United Kingdom