At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 416 enrolled
Drug / intervention
Dotarem (gadoterate meglumine) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.
In Brief
A Phase 3 clinical trial evaluating Dotarem (gadoterate meglumine) and Magnevist (gadopentetate dimeglumine) for Diagnostic Self Evaluation and Central Nervous System Diseases. Completed, enrolled 416 participants across 52 sites in 11 countries.
Detailed Summary
The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Austria, Brazil, Chile, France, Germany, Italy, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedSep 2010
Primary CompletionNov 2011
TodayJul 2026
First PostedSep 30, 2010
Enrollment StartSep 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.8 years ago
Interventions
Dotarem (gadoterate meglumine)drug
0.1 mmol/kg by body weight, single IV injection
Magnevist (gadopentetate dimeglumine)drug
0.1 mmol/kg by body weight, single IV injection