NCT00323310

Safety and Efficacy of MultiHance in Pediatric Patients

A Phase III Multi-Center Open Label Study to Evaluate Safety and Efficacy of MultiHance at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.

Conditions

• Central Nervous System Diseases

Interventions

Type	Name	Description
DRUG	gadobenate dimeglumine	A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2006-05-09
• Last updated: 2010-10-22
• Results posted: 2010-10-06

Locations

1 site across 1 country: United States