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NCT03996447 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
A Phase 3 study of Blood Brain Barrier Defect and CNS Lesion, sponsored by Guerbet.
- Completed
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
- 20
- Study locations
NCT03996447: Completed Phase 3 study of Blood Brain Barrier Defect and CNS Lesion, sponsored by Guerbet.
NCT03996447 is a Phase 3 study of Blood Brain Barrier Defect and CNS Lesion that has completed, run by Guerbet. The registered enrollment target is 260 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03996447, a Phase 3 study of Blood Brain Barrier Defect and CNS Lesion, has completed, sponsored by Guerbet.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Primary Outcome
The lesion visualization (per patient) was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 =
Conditions Studied
Interventions
- DRUG gadopiclenol
- DRUG Gadobutrol 1Mmol/mL Solution for Injection Vial
Study Locations (20)
Other
- ZNA Middelheim - Antwerp
- UZ Brussel - Campus Jette - Brussels
- CHRU - Hôpital Roger Salengro - Neurologie - Lille
- Centre Hospitalier Sainte-Anne - Paris
- CHU La Miletrie - Poitiers
- CHRU Strasbourg Hôpital de Hautepierre - Strasbourg
- Uniklinik Mannheim - Mannheim
- Semmelweis Egyetem - Neurology - Budapest
- Orszagos Klinikai Idegtudomanyi Intezet - Budapest
- Debreceni Egyetem Klinikai Kozpont - Debrecen
- Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika - Pécs
- Szegedi Tudomanyegyetem AOK - Szeged
Illinois
- Northwestern Memorial Hospital - Chicago
- Northwest Neurology, Ltd. - Rolling Meadows
California
- ASCLEPES Research Centers - Panorama City
Connecticut
- University of Connecticut Health Center - Farmington
Missouri
- University of Missouri Hospital and Clinic - Columbia
Pennsylvania
- University Of Pennsylvania - Philadelphia
South Carolina
- South Carolina Clinical & Translational Research (SCTR) Institute - Charleston
Washington
- University Of Washington - Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2020-09-11 |
| Phase | Phase 3 |
What the finished NCT03996447 record still lists
NCT03996447 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Blood Brain Barrier Defect appearing as the primary indexed condition, and to 2 interventions - of which gadopiclenol is the first listed.
NCT03996447 names 20 study sites across 8 states, led by Other, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT03996447 about?
NCT03996447 is a clinical study titled "Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)". This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
What is the current status of trial NCT03996447?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2019-06-03. Estimated completion is 2020-09-11.
What conditions does trial NCT03996447 study?
This clinical trial studies the following conditions: Blood Brain Barrier Defect, CNS Lesion.
What interventions are being tested in trial NCT03996447?
The interventions under investigation include: gadopiclenol (DRUG), Gadobutrol 1Mmol/mL Solution for Injection Vial (DRUG).
Who is sponsoring clinical trial NCT03996447?
This trial is sponsored by Guerbet, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03996447 being conducted?
This trial has 20 study locations across California, Connecticut, Illinois, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03996447's enrollment target sits among peer trials
260 1230th of 2000 higher than 767 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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