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Sponsored by: |
Bracco Diagnostics, Inc |
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Information provided by: | Bracco Diagnostics, Inc |
ClinicalTrials.gov Identifier: | NCT00323310 |
The purpose of this study is 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.
Condition | Intervention | Phase |
---|---|---|
Central Nervous System Diseases |
Drug: gadobenate dimeglumine |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Multi-Center Open Label Study to Evaluate Safety and Efficacy of MultiHance at the Dose of 0.10mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients |
Estimated Enrollment: | 188 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: gadobenate dimeglumine
0.5 M for injection single dose
|
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Bracco Diagnostics, Inc. | |
Princeton, New Jersey, United States, 08540 |
Study Director: | Gianpaolo Pirovano, M.D. | Bracco Diagnostics, Inc |
Responsible Party: | Bracco Diagnostics, Inc ( Gianpaolo Pirovano, Executive Director, Corporate Medical Development ) |
Study ID Numbers: | MH 110 |
Study First Received: | May 5, 2006 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00323310 |
Health Authority: | United States: Food and Drug Administration |
disease of the central nervous system (brain or spine) |
Central Nervous System Diseases |
Nervous System Diseases |